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NCT01393457 Clinical Trial

Cognitive Remediation for Cocaine Dependence

Cocaine Dependence Clinical Trial

Official title:
Cognitive-enhancing DA Medications for Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01393457
Other study ID # DA030787
Secondary ID
Status Completed
Phase Phase 2
First received July 11, 2011
Last updated March 23, 2018
Start date June 2011
Est. completion date February 2017

Study information
Verified date March 2018
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• levodopa/carbidopa
800/200 mg/d
• Ropinirole 2 mg/d
2 mg/d
• Placebo
sugar pill
• Ropinirole 4 mg/d
4 mg/d

Locations
Country Name City State
United States Behavioral and Biomedical Sciences Building Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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. 10 weeks
Secondary Number of Participants Who Completed the 10 Week Trial 10 weeks
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