Cognitive Remediation for Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT01393457

Recruitment Status : Completed

First Posted : July 13, 2011

Results First Posted : March 29, 2018

Last Update Posted : March 29, 2018

Sponsor:

Information provided by (Responsible Party):

Joy Schmitz, The University of Texas Health Science Center, Houston

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cocaine Dependence	Drug: levodopa/carbidopa Drug: Ropinirole 2 mg/d Drug: Placebo Drug: Ropinirole 4 mg/d	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	119 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Cognitive-enhancing DA Medications for Cocaine Dependence
Study Start Date :	June 2011
Actual Primary Completion Date :	February 2017
Actual Study Completion Date :	February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Drug Information available for: Levodopa Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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 Name: ldopa Drug: Ropinirole 2 mg/d 2 mg/d Other Name: 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 Name: ldopa Drug: Ropinirole 4 mg/d 4 mg/d Other Name: Requip
Active Comparator: ldopa levodopa/carbidopa 800/200 mg/d	Drug: levodopa/carbidopa 800/200 mg/d Other Name: ldopa
Placebo Comparator: placebo Placebo	Drug: Placebo sugar pill

Outcome Measures

Primary Outcome 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 Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393457

Locations

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

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

Documents provided by Joy Schmitz, The University of Texas Health Science Center, Houston:

Study Protocol [PDF] September 2, 2011

Statistical Analysis Plan [PDF] September 2, 2011

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Joy Schmitz, Professor - Psychiatry, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT01393457
Other Study ID Numbers:	DA030787
First Posted:	July 13, 2011 Key Record Dates
Results First Posted:	March 29, 2018
Last Update Posted:	March 29, 2018
Last Verified:	March 2018

Keywords provided by Joy Schmitz, The University of Texas Health Science Center, Houston:


cocaine cognition medication treatment

Additional relevant MeSH terms:

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Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Levodopa Carbidopa Ropinirole Antiparkinson Agents	Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Aromatic Amino Acid Decarboxylase Inhibitors Enzyme Inhibitors Dopamine Agonists

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