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CompletedNCT01171183Updated Jul 31, 2015Results posted

Carvedilol for Psychostimulant Dependence

A Phase 2 interventional study of controlled release carvedilol and Placebo in Cocaine Dependence and Cocaine Withdrawal, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by University of Arkansas · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.

02

Conditions studied

  • Cocaine Dependence
  • Cocaine Withdrawal

Keywords

  • cocaine dependence
  • cocaine withdrawal
03

In context

Cocaine-Related Disorders

415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

This study's enrollment of 32 is below the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.

Browse Cocaine-Related Disorders studies →

Lead sponsor

University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-45 years old
  • Cocaine dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
  • At least weekly self-reported cocaine use during a preceding three month period
  • Urine toxicology screen positive for cocaine or cocaine metabolite
  • Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing and not be nursing

Exclusion criteria

Exclusion Criteria:

  • Suicide attempts within the past 12 months or suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
  • Current opioid, alcohol or sedative physical dependence or amphetamine dependence.
  • Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, significant hypertension [i.e., >170 SBP or >110 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
  • Asthma or chronic obstructive pulmonary disease.
  • History of schizophrenia, or bipolar type I disorder.
  • Use of medications that would be expected to have major interaction with carvedilol (e.g., rifampin, cimetidine, digoxin, diuretics).
  • Medical contraindication to receiving carvedilol (e.g., diabetes, severe bradycardia, bronchial asthma or other bronchospastic condition, 2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to carvedilol).
  • Patients currently taking selective serotonin re-uptake inhibitors, antipsychotics and antidepressants (e.g., amitriptyline and imipramine).
  • Liver function tests (i.e., liver enzymes) greater than three times normal levels.
  • Systolic blood pressure > 170 mmHg or \< 90 mmHg, diastolic blood pressure > 110 mmHg or \< 60 mmHg, or heart rate of > 110 beats/min or \< 55 beats/min. Supine blood pressure of 100/65 mm Hg or lower, a seated blood pressure of 90/60 mm Hg or lower, or an orthostatic change of >20mm Hg systolic or 10 mm Hg diastolic on standing.
  • Participants with estimated glomerular filtration rate \< 30 ml/min.
  • Pregnant or nursing female.
05

Study design

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

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Active comparator
    Carvedilol controlled release

    controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing

    Drug: controlled release carvedilol

Interventions

  • Drugcontrolled release carvedilol

    carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper

    Also known as: Coreg CR

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Urine Toxicology Screens

    Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.

    Time frame: based on thrice weekly urine results during the 10-week outpatient phase

Secondary outcomes

  1. Retention

    number of weeks each participant is on study protocol

    Time frame: 12 weeks

07

Results

Posted Jul 31, 2015
Limitations and caveats
Small numbers of participants analyzed. Primary outcome measure based on successfully transition to outpatient phase of the study.

Participant flow

Residential Facility (Weeks 1-2)
Participant flow — Residential Facility (Weeks 1-2)
MilestonePlaceboCarvedilol Controlled Release
Started1516
Completed1310
Not completed26
Withdrew: Withdrawal by subject22
Withdrew: Protocol violation01
Withdrew: Bp outside of study parameters03
Outpatient Participation (Weeks 3-10)
Participant flow — Outpatient Participation (Weeks 3-10)
MilestonePlaceboCarvedilol Controlled Release
Started129
Completed24
Not completed105
Withdrew: Withdrawal by subject22
Withdrew: Lost to follow-up73
Withdrew: Use of contraindicated med: pi term10

Outcome measures

PrimaryUrine Toxicology Screens

Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.

Time frame:
based on thrice weekly urine results during the 10-week outpatient phase
Reported as:
Mean · percentage of cocaine negative urines
Urine Toxicology Screens
percentage of cocaine negative urinesPlaceboCarvedilol Controlled Release
Urine Toxicology Screens38.33 ± 35.2341.85 ± 40.73
Statistical analysis
  • Placebo vs Carvedilol Controlled Release · t-test, 2 sided · p = 0.05 · Median difference (final values): 3.52
SecondaryRetention

number of weeks each participant is on study protocol

Time frame:
12 weeks
Reported as:
Mean · Weeks
Retention
WeeksPlaceboCarvedilol Controlled Release
Retention5.70 ± 4.045.28 ± 5.00
Statistical analysis
  • Placebo vs Carvedilol Controlled Release · t-test, 2 sided · p = 0.05 · Mean difference (final values): -0.73

Adverse events

Collected over during the 12 week trial as well as during the taper period. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/15 (0%)8/15 (53.3%)
Carvedilol Controlled Release—1/15 (6.7%)13/15 (86.7%)
Most frequent serious events
Most frequent serious events
EventPlaceboCarvedilol Controlled Release
Severe disabling hip painMusculoskeletal and connective tissue disorders0/151/15
Most frequent other events
Showing 10 of 29
Most frequent other events
EventPlaceboCarvedilol Controlled Release
lightheaded/dizzyVascular disorders0/153/15
HeadacheNervous system disorders3/151/15
dry mouthGastrointestinal disorders0/152/15
sleep disturbancesNervous system disorders1/152/15
BronchitisRespiratory, thoracic and mediastinal disorders0/152/15
nausea/vomiting and/or diarrheaGastrointestinal disorders1/152/15
RashSkin and subcutaneous tissue disorders2/151/15
ConstipationGastrointestinal disorders0/152/15
vaginal yeast infectionReproductive system and breast disorders0/151/15
cold hand, tingling fingersNervous system disorders1/150/15

Baseline characteristics

Those who were admitted to the residential unit and received at least one dose of medication. The data for one person in the carvedilol arm was excluded from analyses as the person did not meet inclusion criteria for the study and was discharged by the third day.

Age, Categorical
Age, Categorical(Participants)PlaceboCarvedilol Controlled ReleaseTotal
<=18 years000
Between 18 and 65 years151530
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboCarvedilol Controlled ReleaseTotal
Female167
Male14923
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboCarvedilol Controlled ReleaseTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American141226
White134
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)PlaceboCarvedilol Controlled ReleaseTotal
United States151530
08

Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01171183
Lead sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA), Baylor College of Medicine
Responsible party
Sponsor
First posted
Jul 28, 2010
Start date
Aug 2010
Primary completion
May 2014
Completion
May 2014
Results posted
Jul 31, 2015
Last update
Jul 31, 2015

Oversight

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

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