Cognitive Remediation for Cocaine Dependence
Cognitive-enhancing DA Medications for Cocaine Dependence
1 other identifier
interventional
119
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
March 29, 2018
CompletedMarch 29, 2018
March 1, 2018
5.7 years
July 11, 2011
February 23, 2018
March 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Number of Participants Who Completed the 10 Week Trial
10 weeks
Study Arms (4)
ldopa + ropinirole low dose
ACTIVE COMPARATORlevodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d
ldopa + ropinirole high dose
ACTIVE COMPARATORlevodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d
ldopa
ACTIVE COMPARATORlevodopa/carbidopa 800/200 mg/d
placebo
PLACEBO COMPARATORPlacebo
Interventions
800/200 mg/d
Eligibility Criteria
You may qualify if:
- meet criteria for cocaine dependence
- seeking treatment for cocaine dependence
- be in acceptable health based on medical history and physical exam
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Behavioral and Biomedical Sciences Building
Houston, Texas, 77045, United States
Related Publications (1)
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.
PMID: 34600245DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charles Green, PhD
- Organization
- The University of Texas Health Science Center at Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor - Psychiatry
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 13, 2011
Study Start
June 1, 2011
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
March 29, 2018
Results First Posted
March 29, 2018
Record last verified: 2018-03