Trial · NCT01393457
Cognitive Remediation for Cocaine Dependence
NCT01393457, Phase 2, Completed, The University of Texas Health Science Center, Houston; results first posted 2018-03-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cognitive Remediation for Cocaine Dependence. Trials, record NCT01393457. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01393457
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cognitive Remediation for Cocaine Dependence
- NCT number
- NCT01393457
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 119 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Cocaine Dependence
- Interventions
- levodopa/carbidopa, Ropinirole 2 mg/d, Placebo, Ropinirole 4 mg/d
- First posted
- 2011-07-13
- Last updated
- 2018-03-29
- Results first posted
- 2018-03-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Number of Participants Who Completed the 10 Week Trial | 10 weeks |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cocaine Use Based on Urine Drug Screening | 10 weeks | intention to treat | number of negative drug screens | MEAN |
| SECONDARY | Number of Participants Who Completed the 10 Week Trial | 10 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cocaine Use Based on Urine Drug Screening | Ldopa + Ropinirole Low Dose | 20.36 | Standard Deviation 29.51 | number of negative drug screens | |
| Cocaine Use Based on Urine Drug Screening | Ldopa + Ropinirole High Dose | 15.57 | Standard Deviation 21.96 | number of negative drug screens | |
| Cocaine Use Based on Urine Drug Screening | Ldopa | 22.3 | Standard Deviation 28 | number of negative drug screens | |
| Cocaine Use Based on Urine Drug Screening | Placebo | 27.8 | Standard Deviation 30.35 | number of negative drug screens | |
| Number of Participants Who Completed the 10 Week Trial | Ldopa + Ropinirole Low Dose | 14 | participants | ||
| Number of Participants Who Completed the 10 Week Trial | Ldopa + Ropinirole High Dose | 14 | participants | ||
| Number of Participants Who Completed the 10 Week Trial | Ldopa | 16 | participants | ||
| Number of Participants Who Completed the 10 Week Trial | Placebo | 15 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ldopa + Ropinirole Low Dose | 26 | |
| Overall Study | STARTED | Ldopa + Ropinirole High Dose | 26 | |
| Overall Study | STARTED | Ldopa | 31 | |
| Overall Study | STARTED | Placebo | 27 | |
| Overall Study | COMPLETED | Ldopa + Ropinirole Low Dose | 14 | |
| Overall Study | COMPLETED | Ldopa + Ropinirole High Dose | 14 | |
| Overall Study | COMPLETED | Ldopa | 16 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Ldopa + Ropinirole Low Dose | 12 | |
| Overall Study | NOT COMPLETED | Ldopa + Ropinirole High Dose | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Chest pain | Cardiac disorders | Ldopa + Ropinirole Low Dose | 0 | 26 | 0 |
| serious | Chest pain | Cardiac disorders | Ldopa + Ropinirole High Dose | 0 | 26 | 0 |
| serious | Chest pain | Cardiac disorders | Ldopa | 0 | 31 | 0 |
| serious | Chest pain | Cardiac disorders | Placebo | 1 | 27 | 1 |
| serious | Weight gain | Metabolism and nutrition disorders | Ldopa + Ropinirole Low Dose | 0 | 26 | 0 |
| serious | Weight gain | Metabolism and nutrition disorders | Ldopa + Ropinirole High Dose | 0 | 26 | 0 |
| serious | Weight gain | Metabolism and nutrition disorders | Ldopa | 0 | 31 | 0 |
| serious | Weight gain | Metabolism and nutrition disorders | Placebo | 1 | 27 | 1 |
| serious | Gout flare up | Immune system disorders | Ldopa + Ropinirole Low Dose | 0 | 26 | 0 |
| serious | Gout flare up | Immune system disorders | Ldopa + Ropinirole High Dose | 0 | 26 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ldopa + Ropinirole Low Dose | 0 | 26 |
| Total, all-cause mortality | Ldopa + Ropinirole High Dose | 0 | 26 |
| Total, all-cause mortality | Ldopa | 0 | 31 |
| Total, all-cause mortality | Placebo | 0 | 27 |
| Total, other adverse events | Ldopa + Ropinirole Low Dose | 0 | 26 |
| Total, other adverse events | Ldopa + Ropinirole High Dose | 0 | 26 |
| Total, other adverse events | Ldopa | 0 | 31 |
| Total, other adverse events | Placebo | 0 | 27 |
| Total, serious adverse events | Ldopa + Ropinirole Low Dose | 0 | 26 |
| Total, serious adverse events | Ldopa + Ropinirole High Dose | 1 | 26 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34600245 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01393457
GET https://conductscience.org/api/trials/v1/NCT01393457/registered