Cognitive Remediation for Cocaine Dependence

Phase 2

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: levodopa/carbidopa; Drug: Placebo; Drug: Ropinirole 4 mg/d; Drug: Ropinirole 2 mg/d

• Registration Number: NCT01393457
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-13
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Results First Submitted: 2018-02-23
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-23
• Last Update Submitted: 2018-03-23
• Results First Posted: 2018-03-29
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ldopa + ropinirole high dose	Ropinirole 4 mg/d	levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d
ldopa + ropinirole low dose	levodopa/carbidopa	levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d
ldopa + ropinirole low dose	Ropinirole 2 mg/d	levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d
placebo	Placebo	Placebo
ldopa + ropinirole high dose	levodopa/carbidopa	levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d
ldopa	levodopa/carbidopa	levodopa/carbidopa 800/200 mg/d

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants Who Completed the 10 Week Trial	10 weeks

Trial Locations

Locations (1)

Behavioral and Biomedical Sciences Building; 🇺🇸 Houston, Texas, United States