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Cognitive Remediation for Cocaine Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01393457
First Posted: July 13, 2011
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston
  Purpose
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 Intervention Phase
Cocaine Dependence Drug: levodopa/carbidopa Drug: Ropinirole Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Joy Schmitz, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Cocaine use [ Time Frame: 9 weeks ]
    Use of cocaine based on self-report and urine drug screen


Secondary Outcome Measures:
  • Cognitive function [ Time Frame: 9 weeks ]
    Performance on behavioral laboratory tasks measuring cognitive function (e.g., impulsvity, decision-making, motivation, attentional bias).


Estimated Enrollment: 200
Study Start Date: June 2011
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 or 4 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
2 or 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
Drug: Placebo
sugar pill
Placebo Comparator: placebo
Placebo
Drug: Placebo
sugar pill

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
United States, Texas
Behavioral and Biomedical Sciences Building
Houston, Texas, United States, 77045
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
  More Information

Responsible Party: Joy Schmitz, Professor - Psychiatry, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01393457     History of Changes
Other Study ID Numbers: DA030787
First Submitted: July 11, 2011
First Posted: July 13, 2011
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by Joy Schmitz, The University of Texas Health Science Center, Houston:
cocaine
cognition
medication
treatment

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Levodopa
Carbidopa
Ropinirole
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Dopamine Agonists