CClinicalTrials.gg
Sign In
CompletedNCT02046200Updated Aug 8, 2018Results posted

Development of Ivermectin for Alcohol Use Disorders

A Phase 1/2 interventional study of Ivermectin and Placebo in Alcohol Use Disorder, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-08.

Sponsored by University of California, Los Angeles · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the development of effective treatments for AUDs represents an important public health objective. Repositioning, i.e. using existing approved drugs for other indications, represents a fast and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting that it may be useful in the treatment of AUDs in humans. The goal of this project is to provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to treat AUDs.

Read the detailed description

Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the development of effective treatments for AUDs represents an important public health objective. Repositioning, i.e. using existing approved drugs for other indications, represents a fast and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting that it may be useful in the treatment of AUDs in humans. The goal of this project is to provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to treat AUDs. We will enroll 10 alcohol dependent individuals in a placebo-controlled randomized pilot safety trial of IVM (30 mg orally once) over a 2-day (1-night) inpatient stay at the UCLA CTRC and employ a well-characterized battery of behavioral paradigms (i.e., alcohol administration and cue exposure). The goals of the study are to test: (a) the safety of combining IVM, at a dose currently shown to be safe in humans (30 mg), with moderate doses of alcohol (0.08 g/dl); and (b) whether IVM reduces the reinforcing effects of alcohol during alcohol administration and whether it reduces alcohol craving during cue exposure, as compared to placebo.

02

Conditions studied

  • Alcohol Use Disorder

Keywords

  • ivermectin, alcoholism, alcohol use disorder, treatment
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 11 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age between 21 and 65;
  • meet current DSM-V diagnostic criteria for an alcohol use disorder

Exclusion criteria

Exclusion Criteria:

  • current treatment for alcohol problems, a history of treatment in the 30 days before enrollment or current treatment seeking;
  • a current (last 12 months) DSM-V diagnosis of dependence on any psychoactive substances other than alcohol and nicotine;
  • a lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
  • positive urine screen for narcotics, amphetamines, or sedative hypnotics;
  • serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R);
  • pregnancy, nursing, or refusal to use reliable method of birth control (if female);
  • a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes);
  • AST, ALT, or GGT ≥ 3 times upper normal limit;
  • currently on prescription medication that contraindicates use of IVN;
  • any other circumstances that, in the opinion of the investigators, compromises participant safety.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Ivermectin

    Ivermectin 30 mg single dose

    Drug: Ivermectin · Drug: Alcohol

  • Placebo comparator
    Sugar pill

    Matched placebo, single dose

    Drug: Placebo · Drug: Alcohol

Interventions

  • DrugIvermectin

    Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin.

    Also known as: Stromectol

  • DrugPlacebo

    Matched placebo

    Also known as: Sugar pill

  • DrugAlcohol

    Also known as: 5% ethanol IV solution

06

What researchers measure

Primary outcomes

  1. Heart Rate

    Heart rate (measured in beats per minute; BPM) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). During the infusion, the times for collecting HR will vary based on how long it takes participants to reach the targeted BrACs.

    Time frame: Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl

  2. Systolic Blood Pressure

    Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs.

    Time frame: Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl

  3. Diastolic Blood Pressure

    Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs.

    Time frame: Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl

  4. Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)

    Subjective effects of alcohol will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (1 = strongly disagree, 7 = strongly agree).

    Time frame: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.

  5. Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale

    Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Do you feel any drug effects?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).

    Time frame: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.

  6. Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale

    Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Do you like the effects you are feeling right now?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).

    Time frame: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.

  7. Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale

    Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Would you like more of the drug right now?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).

    Time frame: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.

  8. Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale

    Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Are you high?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).

    Time frame: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.

  9. Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale

    Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Stimulant Subscale ranges from 0 to 70. Mean scores across all subjects are reported below.

    Time frame: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.

  10. Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale

    Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Sedative Subscale ranges from 0 to 70. Mean scores across subjects are reported below.

    Time frame: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.

  11. Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ)

    Cue-induced craving will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (0 = strongly disagree, 6 = strongly agree). Item scores were averaged and the total score also ranges from 0-6.

    Time frame: 6 hours post-medication administration

  12. Adverse Effects

    Adverse effects will be monitored to determine the safe of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl) using the Systematic Assessment for Treatment Emergent Effects (SAFTEE). The SAFTEE is a 24-item checklist in which the participant can identify whether a symptom is present (yes/no), its severity (mild, moderate, severe) and whether it was caused by the medication (yes/no). Data below represents a count of individual adverse effects reported on the SAFTEE during the alcohol infusion.

    Time frame: During alcohol infusion at BrAC = 0.00, 0.04, 0.08 g/dl

Secondary outcomes

  1. Ivermectin Pharmacokinetics: Peak Concentration (Cmax)

    This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Maximum plasma concentration (Cmax), measured in ng/mL, provided below.

    Time frame: Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48

  2. Ivermectin Pharmacokinetics: Time to Cmax (Tmax)

    This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Time to Cmax (Tmax), measured in hours, provided below.

    Time frame: Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48

  3. Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC)

    This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Area under the time-concentration curve (AUC) from 0 to 48 hours after IVM administration, provided below.

    Time frame: Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48

  4. Ivermectin Pharmacokinetics: Half-life (T1/2)

    This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Half-life of ivermectin (T1/2), measured in hours, provided below.

    Time frame: Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48

  5. Stress-induced Alcohol Craving

    Alcohol Urge Questionnaire (AUQ)

    Time frame: pre-post exposure to an imaginal stress script

07

Results

Posted Apr 13, 2017

Participant flow

First Intervention (1 Day)
Participant flow — First Intervention (1 Day)
MilestoneIVM 30mg First, Then PlaceboPlacebo First, Then IVM 30 mg
Started56
Completed56
Not completed00
Second Intervention (1 Day)
Participant flow — Second Intervention (1 Day)
MilestoneIVM 30mg First, Then PlaceboPlacebo First, Then IVM 30 mg
Started56
Completed56
Not completed00

Outcome measures

PrimaryHeart Rate

Heart rate (measured in beats per minute; BPM) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). During the infusion, the times for collecting HR will vary based on how long it takes participants to reach the targeted BrACs.

Time frame:
Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl
Reported as:
Mean · BPM
Heart Rate
BPMPlaceboIVM 30mg
0 hours post-med64.57 ± 9.7468.36 ± 20.47
0.5 hours post-med66.82 ± 10.9162.82 ± 11.46
1 hour post-med66.09 ± 12.0164.27 ± 11.60
2 hours post-med65.18 ± 13.8861.18 ± 11.03
4 hours post-med66.73 ± 10.6061.55 ± 12.36
6 hours post-med63.27 ± 12.6659.73 ± 12.62
8 hours post-med66.36 ± 13.4462.18 ± 11.76
10 hours post-med64.70 ± 14.3362.64 ± 10.19
12 hours post-med72.45 ± 13.4173.64 ± 9.31
16 hours post-med61.18 ± 12.0858.09 ± 10.97
24 hours post-med62.55 ± 11.0964.64 ± 10.58
48 hours post-med69.18 ± 10.1569.45 ± 12.49
BrAC = 063.09 ± 12.6961.00 ± 11.80
BrAC = 0.0267.27 ± 14.0063.36 ± 9.00
BrAC = 0.0466.91 ± 10.8961.82 ± 9.16
BrAC = 0.0666.64 ± 12.8363.09 ± 9.82
BrAC = 0.0866.36 ± 12.3761.27 ± 8.21
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.0563
PrimarySystolic Blood Pressure

Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs.

Time frame:
Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl
Reported as:
Mean · mmHg
Systolic Blood Pressure
mmHgPlaceboIVM 30mg
0 hours post-med121 ± 11.10111.64 ± 17.35
0.5 hours post-med118.64 ± 10.67117 ± 12.61
1 hour post-med120.64 ± 11.44116.27 ± 11.80
2 hours post-med121.27 ± 10.59118.27 ± 12.48
4 hours post-med117 ± 12.15111.91 ± 12.85
6 hours post-med117.27 ± 16.17119.55 ± 15.33
8 hours post-med115.18 ± 13.50107.27 ± 10.56
10 hours post-med116.70 ± 13.49114.09 ± 13.63
12 hours post-med116.09 ± 9.17119.63 ± 7.99
16 hours post-med115.64 ± 17.19115.45 ± 8.85
24 hours post-med122 ± 11.61122.73 ± 8.72
48 hours post-med122.72 ± 8.67121.09 ± 9.47
BrAC = 0120.27 ± 15.07114.36 ± 12.75
BrAC = 0.02118.55 ± 10.56114.18 ± 12.34
BrAC = 0.04116.55 ± 12.36111.27 ± 10.72
BrAC = 0.06112.73 ± 11.40115.18 ± 14.08
BrAC = 0.08112.45 ± 12.60108.82 ± 11.50
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.0342
PrimaryDiastolic Blood Pressure

Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs.

Time frame:
Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl
Reported as:
Mean · mmHg
Diastolic Blood Pressure
mmHgPlaceboIVM 30mg
0 hours post-med79.64 ± 10.2375.55 ± 13.20
0.5 hours post-med77.45 ± 11.4475.18 ± 11.12
1 hour post-med78.82 ± 10.3074.91 ± 10.43
2 hours post-med79.91 ± 8.8076.64 ± 12.14
4 hours post-med74.55 ± 10.8272.18 ± 10.91
6 hours post-med75.36 ± 14.4974.55 ± 11.22
8 hours post-med72.55 ± 10.0569.45 ± 10.46
10 hours post-med75.30 ± 11.8873.82 ± 12.60
12 hours post-med73.64 ± 9.8477.27 ± 6.44
16 hours post-med72.82 ± 12.6973.18 ± 8.81
24 hours post-med76.09 ± 12.3978.09 ± 10.23
48 hours post-med80.55 ± 10.9681.55 ± 10.49
BrAC = 078.18 ± 11.5774.36 ± 12.49
BrAC = 0.0277.91 ± 10.0173.73 ± 10.96
BrAC = 0.0477.55 ± 10.7172.91 ± 11.89
BrAC = 0.0675.27 ± 9.3174.00 ± 12.13
BrAC = 0.0871.91 ± 10.9072.73 ± 10.75
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.1597
PrimarySubjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)

Subjective effects of alcohol will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (1 = strongly disagree, 7 = strongly agree).

Time frame:
During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.
Reported as:
Mean · scores on a scale
Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)
scores on a scalePlaceboIVM 30mg
BrAC = 0.002.58 ± 1.742.90 ± 2.04
BrAC = 0.023.14 ± 1.643.27 ± 1.65
BrAC = 0.043.02 ± 1.643.19 ± 1.60
BrAC = 0.062.73 ± 2.002.60 ± 1.60
BrAC = 0.082.83 ± 1.792.91 ± 1.87
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.7617
PrimarySubjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale

Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Do you feel any drug effects?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).

Time frame:
During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.
Reported as:
Mean · scores on a scale
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale
scores on a scalePlaceboIVM 30mg
BrAC = 0.001.36 ± 2.660.91 ± 1.30
BrAC = 0.022.73 ± 2.453.45 ± 2.21
BrAC = 0.043.82 ± 2.754.82 ± 3.03
BrAC = 0.064.45 ± 3.485.36 ± 3.33
BrAC = 0.085.27 ± 3.296.36 ± 2.80
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.93
PrimarySubjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale

Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Do you like the effects you are feeling right now?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).

Time frame:
During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.
Reported as:
Mean · scores on a scale
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale
scores on a scalePlaceboIVM 30mg
BrAC = 0.004.09 ± 1.704.09 ± 2.02
BrAC = 0.025.36 ± 1.635.36 ± 3.20
BrAC = 0.046.18 ± 2.525.55 ± 2.95
BrAC = 0.066.64 ± 2.986.36 ± 3.44
BrAC = 0.086.45 ± 3.336.27 ± 3.50
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.95
PrimarySubjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale

Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Would you like more of the drug right now?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).

Time frame:
During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.
Reported as:
Mean · scores on a scale
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale
scores on a scalePlaceboIVM 30mg
BrAC = 0.001.64 ± 2.253.18 ± 4.00
BrAC = 0.024.91 ± 4.096.27 ± 4.52
BrAC = 0.045.45 ± 3.966.00 ± 3.95
BrAC = 0.065.00 ± 3.925.64 ± 4.03
BrAC = 0.085.27 ± 4.255.55 ± 4.78
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.43
PrimarySubjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale

Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Are you high?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).

Time frame:
During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.
Reported as:
Mean · scores on a scale
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale
scores on a scalePlaceboIVM 30mg
BrAC = 0.000.91 ± 1.700.09 ± 0.30
BrAC = 0.022.64 ± 2.293.27 ± 2.01
BrAC = 0.044.00 ± 2.935.36 ± 2.66
BrAC = 0.064.91 ± 3.565.73 ± 2.57
BrAC = 0.085.09 ± 3.626.00 ± 2.79
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.06
PrimarySubjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale

Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Stimulant Subscale ranges from 0 to 70. Mean scores across all subjects are reported below.

Time frame:
During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.
Reported as:
Mean · scores on a scale
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale
scores on a scalePlaceboIVM 30mg
BrAC = 0.0018.09 ± 13.3717.36 ± 12.99
BrAC = 0.0220.00 ± 11.9123.73 ± 14.29
BrAC = 0.0421.73 ± 15.0420.09 ± 13.32
BrAC = 0.0625.91 ± 19.0322.64 ± 15.74
BrAC = 0.0826.18 ± 20.1720.91 ± 15.00
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.21
PrimarySubjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale

Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Sedative Subscale ranges from 0 to 70. Mean scores across subjects are reported below.

Time frame:
During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.
Reported as:
Mean · scores on a scale
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale
scores on a scalePlaceboIVM 30mg
BrAC = 0.0014.18 ± 14.6710.64 ± 9.97
BrAC = 0.0211.00 ± 13.1013.09 ± 14.80
BrAC = 0.0410.91 ± 14.7216.00 ± 15.75
BrAC = 0.0615.27 ± 17.4116.73 ± 19.22
BrAC = 0.0815.27 ± 18.9316.64 ± 17.32
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.09
PrimaryCue-induced Craving Using the Alcohol Urge Questionnaire (AUQ)

Cue-induced craving will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (0 = strongly disagree, 6 = strongly agree). Item scores were averaged and the total score also ranges from 0-6.

Time frame:
6 hours post-medication administration
Reported as:
Mean · scores on a scale
Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ)
scores on a scalePlaceboIVM 30mg
Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ)3.59 ± 1.694.07 ± 1.34
Statistical analysis
  • Placebo vs IVM 30mg · ANOVA · p = 0.99
PrimaryAdverse Effects

Adverse effects will be monitored to determine the safe of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl) using the Systematic Assessment for Treatment Emergent Effects (SAFTEE). The SAFTEE is a 24-item checklist in which the participant can identify whether a symptom is present (yes/no), its severity (mild, moderate, severe) and whether it was caused by the medication (yes/no). Data below represents a count of individual adverse effects reported on the SAFTEE during the alcohol infusion.

Time frame:
During alcohol infusion at BrAC = 0.00, 0.04, 0.08 g/dl
Reported as:
Number · adverse effect count
Adverse Effects
adverse effect countPlacebo (BrAC = 0.00)Placebo (BrAC = 0.04)Placebo (BrAC = 0.08)IVM 30mg (BrAC = 0.00)IVM 30mg (BrAC = 0.04)IVM 30mg (BrAC = 0.08)
Abdominal pain/cramps011000
Yellow eyes000000
Nausea or vomiting000000
Irritability or anger100000
Increased desire for sex101121
Nervousness100100
Ringing in the ears000000
Decrease in appetite000000
Depression000000
Fatigue122112
Difficulty in staying awake334322
Increase in appetite013124
Blurred vision111011
Drowsiness242245
Headache000010
Night sweats000000
Mental confusion000000
Anxiety000010
Joint or muscle pain000000
Dizziness000012
Sexual problems000000
Difficulty sleeping000000
Fever or chills000000
Decreased desire for sex000000
SecondaryIvermectin Pharmacokinetics: Peak Concentration (Cmax)

This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Maximum plasma concentration (Cmax), measured in ng/mL, provided below.

Time frame:
Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48
Reported as:
Mean · ng/mL
Ivermectin Pharmacokinetics: Peak Concentration (Cmax)
ng/mLIVM 30mg
Ivermectin Pharmacokinetics: Peak Concentration (Cmax)406.03 ± 398.36
SecondaryIvermectin Pharmacokinetics: Time to Cmax (Tmax)

This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Time to Cmax (Tmax), measured in hours, provided below.

Time frame:
Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48
Reported as:
Mean · hours
Ivermectin Pharmacokinetics: Time to Cmax (Tmax)
hoursIVM 30mg
Ivermectin Pharmacokinetics: Time to Cmax (Tmax)9.09 ± 3.62
SecondaryIvermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC)

This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Area under the time-concentration curve (AUC) from 0 to 48 hours after IVM administration, provided below.

Time frame:
Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48
Reported as:
Mean · ng*h/mL
Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC)
ng*h/mLIVM 30mg
Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC)5078 ± 4258
SecondaryIvermectin Pharmacokinetics: Half-life (T1/2)

This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Half-life of ivermectin (T1/2), measured in hours, provided below.

Time frame:
Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48
Reported as:
Mean · hours
Ivermectin Pharmacokinetics: Half-life (T1/2)
hoursIVM 30mg
Ivermectin Pharmacokinetics: Half-life (T1/2)15.75 ± 6.86
SecondaryStress-induced Alcohol Craving

Alcohol Urge Questionnaire (AUQ)

Time frame:
pre-post exposure to an imaginal stress script

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IVM 30mg—0/11 (0%)0/11 (0%)
Placebo—0/11 (0%)0/11 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)IVM 30mg; Placebo
Mean38.82 ± 11.39
Sex: Female, Male
Sex: Female, Male(Participants)IVM 30mg; Placebo
Female2
Male9
Meets criteria for DSM-V AD
Meets criteria for DSM-V AD(participants)IVM 30mg; Placebo
Number11
08

Study locations

1 site
  • UCLA Addictions Laboratory
    Los Angeles, California 90095, United States
09

References and documents

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02046200
Lead sponsor
University of California, Los Angeles
Responsible party
Lara Ray, PhD (Associate Professor, University of California, Los Angeles) — Principal investigator
First posted
Jan 27, 2014
Start date
Feb 2014
Primary completion
Mar 2015
Completion
Mar 2015
Results posted
Apr 13, 2017
Last update
Aug 8, 2018

Study contacts

Lara Ray, PhD
principal investigator · University of California, Los Angeles
Daniel Roche, PhD
study director · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Alcoholism→

Other studies from this sponsor

University of California, Los Angeles

Start the discussion