Cognitive Remediation for Cocaine Dependence

NCT ID: NCT01393457

Last Updated: 2018-03-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2017-02-28

Brief Summary

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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

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Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ldopa + ropinirole low dose

levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d

Group Type ACTIVE_COMPARATOR

levodopa/carbidopa

Intervention Type DRUG

800/200 mg/d

Ropinirole 2 mg/d

Intervention Type DRUG

2 mg/d

ldopa + ropinirole high dose

levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d

Group Type ACTIVE_COMPARATOR

levodopa/carbidopa

Intervention Type DRUG

800/200 mg/d

Ropinirole 4 mg/d

Intervention Type DRUG

4 mg/d

ldopa

levodopa/carbidopa 800/200 mg/d

Group Type ACTIVE_COMPARATOR

levodopa/carbidopa

Intervention Type DRUG

800/200 mg/d

placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

sugar pill

Interventions

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levodopa/carbidopa

800/200 mg/d

Intervention Type DRUG

Ropinirole 2 mg/d

2 mg/d

Intervention Type DRUG

Placebo

sugar pill

Intervention Type DRUG

Ropinirole 4 mg/d

4 mg/d

Intervention Type DRUG

Other Intervention Names

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ldopa Requip Requip

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Joy Schmitz

Professor - Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Behavioral and Biomedical Sciences Building

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34600245 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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DA030787

Identifier Type: -

Identifier Source: org_study_id

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