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
This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.
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 →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.
Exclusion Criteria:
Drug: Placebo
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
Drug: controlled 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
Placebo
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
Retention
number of weeks each participant is on study protocol
Time frame: 12 weeks
| Milestone | Placebo | Carvedilol Controlled Release |
|---|---|---|
| Started | 15 | 16 |
| Completed | 13 | 10 |
| Not completed | 2 | 6 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Bp outside of study parameters | 0 | 3 |
| Milestone | Placebo | Carvedilol Controlled Release |
|---|---|---|
| Started | 12 | 9 |
| Completed | 2 | 4 |
| Not completed | 10 | 5 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Lost to follow-up | 7 | 3 |
| Withdrew: Use of contraindicated med: pi term | 1 | 0 |
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.
| percentage of cocaine negative urines | Placebo | Carvedilol Controlled Release |
|---|---|---|
| Urine Toxicology Screens | 38.33 ± 35.23 | 41.85 ± 40.73 |
number of weeks each participant is on study protocol
| Weeks | Placebo | Carvedilol Controlled Release |
|---|---|---|
| Retention | 5.70 ± 4.04 | 5.28 ± 5.00 |
Collected over during the 12 week trial as well as during the taper period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/15 (0%) | 8/15 (53.3%) |
| Carvedilol Controlled Release | — | 1/15 (6.7%) | 13/15 (86.7%) |
| Event | Placebo | Carvedilol Controlled Release |
|---|---|---|
| Severe disabling hip painMusculoskeletal and connective tissue disorders | 0/15 | 1/15 |
| Event | Placebo | Carvedilol Controlled Release |
|---|---|---|
| lightheaded/dizzyVascular disorders | 0/15 | 3/15 |
| HeadacheNervous system disorders | 3/15 | 1/15 |
| dry mouthGastrointestinal disorders | 0/15 | 2/15 |
| sleep disturbancesNervous system disorders | 1/15 | 2/15 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 0/15 | 2/15 |
| nausea/vomiting and/or diarrheaGastrointestinal disorders | 1/15 | 2/15 |
| RashSkin and subcutaneous tissue disorders | 2/15 | 1/15 |
| ConstipationGastrointestinal disorders | 0/15 | 2/15 |
| vaginal yeast infectionReproductive system and breast disorders | 0/15 | 1/15 |
| cold hand, tingling fingersNervous system disorders | 1/15 | 0/15 |
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(Participants) | Placebo | Carvedilol Controlled Release | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 15 | 30 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo | Carvedilol Controlled Release | Total |
|---|---|---|---|
| Female | 1 | 6 | 7 |
| Male | 14 | 9 | 23 |
| Race (NIH/OMB)(Participants) | Placebo | Carvedilol Controlled Release | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 12 | 26 |
| White | 1 | 3 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Carvedilol Controlled Release | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
University of Arkansas