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CompletedNCT00667875NALAPZUpdated Sep 29, 2017Results posted

An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

A Phase 2 interventional study of Placebo and Naltrexone in Alcohol Dependence, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-09-29.

Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.

02

Conditions studied

  • Alcohol Dependence

Keywords

  • Alcohol Dependence
  • Alcoholism
  • Naltrexone
  • Aripiprazole
  • Substance Abuse
03

In context

Alcoholism

1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 65 is below the median of 88 across 1,395 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.

Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.

Browse Medical University of South Carolina studies →

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 70

  2. Subjects will meet criteria for primary alcohol dependence operationalized as follows:

    A. Meets the DSM IV criteria for alcohol dependence including loss of control over drinking (criterion 3) B. Has not had more than one previous inpatient medical detoxification

  3. Consumes, on average, at least 10 standard drinks per drinking day for men and 8 drinks per day for women in the 90 days pre-screening (to select an appropriately heavy drinking population)
  4. Able to maintain sobriety for four days (with or without the aid of alcohol detoxification medications) as determined by self report, collateral report, and breathalyzer measurements
  5. Able to read and understand questionnaires and informed consent
  6. Lives within approximately 50 miles of the study site -

Exclusion criteria

Exclusion Criteria:

  1. Currently meets DSM IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
  2. Ever abused opiates
  3. Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen
  4. Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder
  5. Meets DSM IV current criteria for dissociative disorder or eating disorders
  6. Has current suicidal ideation or homicidal ideation
  7. Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications
  8. Current use of disulfiram
  9. Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
  10. Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days abstinence
  11. Sexually active female of child-bearing potential who is pregnant (by urine HCG), nursing, or who is not using a reliable form of birth control
  12. Has current charges pending for a violent crime (not including DUI-related offenses)
  13. Does not have a stable living situation and a reliable source of collateral reporting
  14. Has taken an opiate antagonist drug in the last month
  15. Has taken aripiprazole in the last month or has experienced adverse effects from it at any time in the past
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Placebo comparator
    1

    Drug: Placebo

  • Active comparator
    2

    Naltrexone

    Drug: Naltrexone

  • Active comparator
    3

    Naltrexone + Aripiprazole

    Drug: Naltrexone + Aripiprazole

Interventions

  • DrugPlacebo

    placebo

  • DrugNaltrexone

    Naltrexone (25mg or 50 mg per titration schedule)

  • DrugNaltrexone + Aripiprazole

    Drug pages: Naltrexone · Aripiprazole

    Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)

06

What researchers measure

Primary outcomes

  1. Drinks Per Drinking Day

    Standard drinks per drinking day

    Time frame: 16-week treatment period

  2. Percent Heavy Drinking Days

    percent of total 112 day trial in which heavy drinking occurred (\>=4 for females, \>=5 male)

    Time frame: 16 weeks

Secondary outcomes

  1. Pill Counts During Treatment

    Compliance with medication as determined by pill counts

    Time frame: 16-week

  2. Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance

    Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime

    Time frame: 16 weeks treatment trial

07

Results

Posted Apr 18, 2016

Participant flow

Subjects were recruited from the community in response to advertising in local papers, and radio

Participant flow — Overall Study
Milestone1 Placebo2 Naltrexone3 Naltrexone Plus Aripiprazole
Started232121
Subjects included in analysisd202119
Completed13108
Not completed101113
Withdrew: Adverse event026
Withdrew: Withdrawal by subject1097

Outcome measures

PrimaryDrinks Per Drinking Day

Standard drinks per drinking day

Time frame:
16-week treatment period
Reported as:
Mean · drinks per drinking day
Drinks Per Drinking Day
drinks per drinking dayInactive PlaceboNaltrexone and Inactive Placebo AripiprazoleNaltrexone + Aripiprazole
Drinks Per Drinking Day7.2 ± 7.37.8 ± 6.65.2 ± 7.2
Statistical analysis
  • Inactive Placebo vs Naltrexone and Inactive Placebo Aripiprazole vs Naltrexone + Aripiprazole · Mixed Models Analysis · p = 0.49 (The p value represents variation of the total 16 week trial over all three groups.)
PrimaryPercent Heavy Drinking Days

percent of total 112 day trial in which heavy drinking occurred (\>=4 for females, \>=5 male)

Time frame:
16 weeks
Reported as:
Mean · percent of days
Percent Heavy Drinking Days
percent of daysPlacebo: PlaceboNaltrexone: Placebo AripiprazoleNaltrexone:Aripiprazole
Percent Heavy Drinking Days10.54 ± 20.016.7 ± 19.97.34 ± 19.7
Statistical analysis
  • Placebo: Placebo vs Naltrexone: Placebo Aripiprazole vs Naltrexone:Aripiprazole · Mixed Models Analysis · p = 0.03 (The p value represents variation of the total 16 week trial over all three groups.)
SecondaryPill Counts During Treatment

Compliance with medication as determined by pill counts

Time frame:
16-week
Reported as:
Mean · Percent of pills taken
Pill Counts During Treatment
Percent of pills taken1 Placebo2 Naltrexone3 Naltrexone Plus Aripiprazole
Percent aripiprazole or aripiprazole placebo taken96.4 ± 6.597.0 ± 4.784.2 ± 25.2
Percent naltrexone or naltrexone placebo taken96.8 ± 5.996.9 ± 4.286.4 ± 22.7
Statistical analysis
  • 1 Placebo vs 2 Naltrexone vs 3 Naltrexone Plus Aripiprazole · ANOVA · p = <.05Naltrexone or naltrexone placebo pills taken F=3.9 df 2 Aripiprazole or aripiprazole placebo pills taken F=4.6 df 2
SecondaryPercent Riboflavin Positive Urine Samples as a Measure of Medication Compliance

Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime

Time frame:
16 weeks treatment trial
Reported as:
Mean · Percent of riboflavin positive samples
Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance
Percent of riboflavin positive samplesPlacebo: PlaceboNaltrexone: Placebo AripiprazoleNaltrexone:Aripiprazole
Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance74.9 ± 33.785.1 ± 18.562.1 ± 30.9
Statistical analysis
  • Placebo: Placebo vs Naltrexone: Placebo Aripiprazole vs Naltrexone:Aripiprazole · ANOVA · p = <.05f 3.2 df 2

Adverse events

Collected over Adverse event data were collected over 16 weeks following randomization visit.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Inactive Placebo0/23 (0%)0/23 (0%)21/23 (91.3%)
Naltrexone and Inactive Placebo Aripiprazole0/21 (0%)0/21 (0%)20/21 (95.2%)
Naltrexone + Aripiprazole0/21 (0%)0/21 (0%)19/21 (90.5%)
Most frequent other events
Most frequent other events
EventInactive PlaceboNaltrexone and Inactive Placebo AripiprazoleNaltrexone + Aripiprazole
Fatigue or tirednessGeneral disorders10/2316/2112/21
Nervousness/anxietyNervous system disorders12/2313/2111/21
HeadacheGeneral disorders14/2310/219/21
Nausea and/or vomitingGastrointestinal disorders6/2312/2110/21
InsomniaGeneral disorders9/2312/219/21
DizzinessGeneral disorders6/239/2110/21
SomnolenceGeneral disorders7/239/215/21
DiarrheaGastrointestinal disorders4/238/213/21

Baseline characteristics

Age, Continuous
Age, Continuous(years)1 Placebo2 Naltrexone3 Naltrexone Plus AripiprazoleTotal
Mean47 ± 9.647.2 ± 11.348.4 ± 10.247.6 ± 10.2
Sex: Female, Male
Sex: Female, Male(Participants)1 Placebo2 Naltrexone3 Naltrexone Plus AripiprazoleTotal
Female77923
Male16141242
08

Study locations

1 site
  • Medical University of South Carolina, Center for Drug and Alcohol Programs
    Charleston, South Carolina 29425, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00667875
Lead sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Raymond F. Anton (Distringuished University Professor, Medical University of South Carolina) — Principal investigator
First posted
Apr 28, 2008
Start date
Apr 2008
Primary completion
May 2011
Completion
May 2011
Results posted
Apr 18, 2016
Last update
Sep 29, 2017

Study contacts

Raymond F Anton, M.D.
principal investigator · Medical University of South Carolina

Oversight

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

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