Cocaine Dependence
Conditions
Keywords
cocaine, cognition, medication, treatment
Brief summary
The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.
Interventions
800/200 mg/d
DRUGRopinirole 2 mg/d
2 mg/d
DRUGPlacebo
sugar pill
DRUGRopinirole 4 mg/d
4 mg/d
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* meet criteria for cocaine dependence * seeking treatment for cocaine dependence * be in acceptable health based on medical history and physical exam
Exclusion criteria
* dependent on drugs other than cocaine, nicotine, marijuana * have a medical condition contraindicating treatment with study medications * having conditions of probation or parole requiring reports of drug use to officers of the court
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cocaine Use Based on Urine Drug Screening | 10 weeks | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Completed the 10 Week Trial | 10 weeks |
Countries
United States
Participant flow
Pre-assignment details
119 were enrolled (that is, signed the consent); however, only 110 were randomized. Of the 9 that were not enrolled but not randomized, 1 was no longer interested after signing the consent, and 8 were lost to follow up.
Participants by arm
| Arm | Count |
|---|---|
| Ldopa + Ropinirole Low Dose levodopa/carbidopa: 800/200 mg/d
Ropinirole 2 mg/d: 2 mg/d | 26 |
| Ldopa + Ropinirole High Dose levodopa/carbidopa: 800/200 mg/d
Ropinirole 4 mg/d: 4 mg/d | 26 |
| Ldopa levodopa/carbidopa 800/200 mg/d | 31 |
| Placebo Placebo | 27 |
| Total | 110 |
Baseline characteristics
| Characteristic | Placebo | Total | Ldopa + Ropinirole Low Dose | Ldopa + Ropinirole High Dose | Ldopa |
|---|---|---|---|---|---|
| Age, Continuous | 47.11 years STANDARD_DEVIATION 8.56 | 46.6 years STANDARD_DEVIATION 7.93 | 44.96 years STANDARD_DEVIATION 6.5 | 46.04 years STANDARD_DEVIATION 8.7 | 48 years STANDARD_DEVIATION 7.87 |
| Number of days of cocaine use over the last 30 days | 14.74 days STANDARD_DEVIATION 8.69 | 16.13 days STANDARD_DEVIATION 8.65 | 16.12 days STANDARD_DEVIATION 8.08 | 16.31 days STANDARD_DEVIATION 9.64 | 17.19 days STANDARD_DEVIATION 8.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 84 Participants | 19 Participants | 19 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 15 Participants | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 27 Participants | 110 Participants | 26 Participants | 26 Participants | 31 Participants |
| Sex: Female, Male Female | 6 Participants | 25 Participants | 7 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 21 Participants | 85 Participants | 19 Participants | 19 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 | 0 / 31 | 0 / 27 |
| other Total, other adverse events | 0 / 26 | 0 / 26 | 0 / 31 | 0 / 27 |
| serious Total, serious adverse events | 0 / 26 | 1 / 26 | 0 / 31 | 3 / 27 |
Outcome results
Primary
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
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ldopa + Ropinirole Low Dose | Cocaine Use Based on Urine Drug Screening | 20.36 number of negative drug screens | Standard Deviation 29.51 |
| Ldopa + Ropinirole High Dose | Cocaine Use Based on Urine Drug Screening | 15.57 number of negative drug screens | Standard Deviation 21.96 |
| Ldopa | Cocaine Use Based on Urine Drug Screening | 22.3 number of negative drug screens | Standard Deviation 28 |
| Placebo | Cocaine Use Based on Urine Drug Screening | 27.8 number of negative drug screens | Standard Deviation 30.35 |
Secondary
Number of Participants Who Completed the 10 Week Trial
Time frame: 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ldopa + Ropinirole Low Dose | Number of Participants Who Completed the 10 Week Trial | 14 participants |
| Ldopa + Ropinirole High Dose | Number of Participants Who Completed the 10 Week Trial | 14 participants |
| Ldopa | Number of Participants Who Completed the 10 Week Trial | 16 participants |
| Placebo | Number of Participants Who Completed the 10 Week Trial | 15 participants |