A Phase 2 interventional study of levodopa/carbidopa and Ropinirole 2 mg/d in Cocaine Dependence, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's enrollment of 119 is above the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d
Drug: levodopa/carbidopa · Drug: Ropinirole 2 mg/d
levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d
Drug: levodopa/carbidopa · Drug: Ropinirole 4 mg/d
levodopa/carbidopa 800/200 mg/d
Drug: levodopa/carbidopa
Placebo
Drug: Placebo
800/200 mg/d
Also known as: ldopa
2 mg/d
Also known as: Requip
sugar pill
4 mg/d
Also known as: Requip
Cocaine Use Based on Urine Drug Screening
The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.
Time frame: 10 weeks
Number of Participants Who Completed the 10 Week Trial
Time frame: 10 weeks
| Milestone | Ldopa + Ropinirole Low Dose | Ldopa + Ropinirole High Dose | Ldopa | Placebo |
|---|---|---|---|---|
| Started | 26 | 26 | 31 | 27 |
| Completed | 14 | 14 | 16 | 15 |
| Not completed | 12 | 12 | 15 | 12 |
The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.
| number of negative drug screens | Ldopa + Ropinirole Low Dose | Ldopa + Ropinirole High Dose | Ldopa | Placebo |
|---|---|---|---|---|
| Cocaine Use Based on Urine Drug Screening | 20.36 ± 29.51 | 15.57 ± 21.96 | 22.3 ± 28 | 27.8 ± 30.35 |
| participants | Ldopa + Ropinirole Low Dose | Ldopa + Ropinirole High Dose | Ldopa | Placebo |
|---|---|---|---|---|
| Number of Participants Who Completed the 10 Week Trial | 14 | 14 | 16 | 15 |
Collected over weekly for 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ldopa + Ropinirole Low Dose | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Ldopa + Ropinirole High Dose | 0/26 (0%) | 1/26 (3.8%) | 0/26 (0%) |
| Ldopa | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Placebo | 0/27 (0%) | 3/27 (11.1%) | 0/27 (0%) |
| Event | Ldopa + Ropinirole Low Dose | Ldopa + Ropinirole High Dose | Ldopa | Placebo |
|---|---|---|---|---|
| Suicide ideationPsychiatric disorders | 0/26 | 1/26 | 0/31 | 0/27 |
| Chest painCardiac disorders | 0/26 | 0/26 | 0/31 | 1/27 |
| Weight gainMetabolism and nutrition disorders | 0/26 | 0/26 | 0/31 | 1/27 |
| Gout flare upImmune system disorders | 0/26 | 0/26 | 0/31 | 1/27 |
| Age, Continuous(years) | Ldopa + Ropinirole Low Dose | Ldopa + Ropinirole High Dose | Ldopa | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 44.96 ± 6.50 | 46.04 ± 8.70 | 48 ± 7.87 | 47.11 ± 8.56 | 46.6 ± 7.93 |
| Sex: Female, Male(Participants) | Ldopa + Ropinirole Low Dose | Ldopa + Ropinirole High Dose | Ldopa | Placebo | Total |
|---|---|---|---|---|---|
| Female | 7 | 7 | 5 | 6 | 25 |
| Male | 19 | 19 | 26 | 21 | 85 |
| Race (NIH/OMB)(Participants) | Ldopa + Ropinirole Low Dose | Ldopa + Ropinirole High Dose | Ldopa | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 19 | 19 | 26 | 20 | 84 |
| White | 2 | 1 | 3 | 3 | 9 |
| More than one race | 1 | 0 | 0 | 1 | 2 |
| Unknown or Not Reported | 4 | 6 | 2 | 3 | 15 |
| Region of Enrollment(Participants) | Ldopa + Ropinirole Low Dose | Ldopa + Ropinirole High Dose | Ldopa | Placebo | Total |
|---|---|---|---|---|---|
| United States | 26 | 26 | 31 | 27 | 110 |
| Number of days of cocaine use over the last 30 days(days) | Ldopa + Ropinirole Low Dose | Ldopa + Ropinirole High Dose | Ldopa | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 16.12 ± 8.08 | 16.31 ± 9.64 | 17.19 ± 8.46 | 14.74 ± 8.69 | 16.13 ± 8.65 |
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The University of Texas Health Science Center, Houston