Cognitive Remediation for Cocaine Dependence

March 23, 2018 updated by: Joy Schmitz, The University of Texas Health Science Center, Houston

Cognitive-enhancing DA Medications for Cocaine Dependence

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77045
        • Behavioral and Biomedical Sciences Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Placebo
Drug: Placebo
sugar pill
ACTIVE_COMPARATOR: ldopa + ropinirole low dose
levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d
Drug: levodopa/carbidopa
800/200 mg/d
Other Names:
  • ldopa
Drug: Ropinirole 2 mg/d
2 mg/d
Other Names:
  • Requip
ACTIVE_COMPARATOR: ldopa + ropinirole high dose
levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d
Drug: levodopa/carbidopa
800/200 mg/d
Other Names:
  • ldopa
Drug: Ropinirole 4 mg/d
4 mg/d
Other Names:
  • Requip
ACTIVE_COMPARATOR: ldopa
levodopa/carbidopa 800/200 mg/d
Drug: levodopa/carbidopa
800/200 mg/d
Other Names:
  • ldopa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (ESTIMATE)

July 13, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA030787

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cocaine Dependence

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe