Cognitive Remediation for Cocaine Dependence

Overview

The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.

Full Title of Study: “Cognitive-enhancing DA Medications for Cocaine Dependence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2017

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: ldopa + ropinirole low dose
    • levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d
  • Active Comparator: ldopa + ropinirole high dose
    • levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d
  • Active Comparator: ldopa
    • levodopa/carbidopa 800/200 mg/d
  • Placebo Comparator: placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Cocaine Use Based on Urine Drug Screening
    • Time Frame: 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 Measures

  • Number of Participants Who Completed the 10 Week Trial
    • Time Frame: 10 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joy Schmitz, Professor – Psychiatry – The University of Texas Health Science Center, Houston

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