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The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ldopa + ropinirole low dose | Active Comparator | levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d |
|
| ldopa + ropinirole high dose | Active Comparator | levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d |
|
| ldopa | Active Comparator | levodopa/carbidopa 800/200 mg/d |
|
| placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levodopa/carbidopa | Drug | 800/200 mg/d |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed the 10 Week Trial | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral and Biomedical Sciences Building | Houston | Texas | 77045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34600245 | Derived | Suchting R, Green CE, de Dios C, Vincent J, Moeller FG, Lane SD, Schmitz JM. Citalopram for treatment of cocaine use disorder: A Bayesian drop-the-loser randomized clinical trial. Drug Alcohol Depend. 2021 Nov 1;228:109054. doi: 10.1016/j.drugalcdep.2021.109054. Epub 2021 Sep 23. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ldopa + Ropinirole Low Dose | levodopa/carbidopa: 800/200 mg/d Ropinirole 2 mg/d: 2 mg/d |
| FG001 | Ldopa + Ropinirole High Dose | levodopa/carbidopa: 800/200 mg/d Ropinirole 4 mg/d: 4 mg/d |
| FG002 | Ldopa | levodopa/carbidopa 800/200 mg/d |
| FG003 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ldopa + Ropinirole Low Dose | levodopa/carbidopa: 800/200 mg/d Ropinirole 2 mg/d: 2 mg/d |
| BG001 | Ldopa + Ropinirole High Dose | levodopa/carbidopa: 800/200 mg/d Ropinirole 4 mg/d: 4 mg/d |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | intention to treat | Posted | Mean | Standard Deviation | number of negative drug screens | 10 weeks |
|
weekly for 10 weeks
Side effects were not considered to be adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ldopa + Ropinirole Low Dose | levodopa/carbidopa: 800/200 mg/d Ropinirole 2 mg/d: 2 mg/d |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Green, PhD | The University of Texas Health Science Center at Houston | 713-500-6402 | charles.green@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2011 | Feb 23, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2011 | Feb 23, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
| C046649 | ropinirole |
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| Ropinirole 2 mg/d | Drug | 2 mg/d |
|
|
| Placebo | Drug | sugar pill |
|
| Ropinirole 4 mg/d | Drug | 4 mg/d |
|
|
| BG002 | Ldopa | levodopa/carbidopa 800/200 mg/d |
| BG003 | Placebo | Placebo |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of days of cocaine use over the last 30 days | Mean | Standard Deviation | days |
|
| Ldopa |
levodopa/carbidopa 800/200 mg/d |
| OG003 | Placebo | Placebo |
|
|
| Secondary | Number of Participants Who Completed the 10 Week Trial | Posted | Number | participants | 10 weeks |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Ldopa + Ropinirole High Dose | levodopa/carbidopa: 800/200 mg/d Ropinirole 4 mg/d: 4 mg/d | 0 | 26 | 1 | 26 | 0 | 26 |
| EG002 | Ldopa | levodopa/carbidopa 800/200 mg/d | 0 | 31 | 0 | 31 | 0 | 31 |
| EG003 | Placebo | Placebo | 0 | 27 | 3 | 27 | 0 | 27 |
| Weight gain | Metabolism and nutrition disorders | Systematic Assessment |
|
| Gout flare up | Immune system disorders | Non-systematic Assessment |
|
| Suicide ideation | Psychiatric disorders | Systematic Assessment |
|
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