Cognitive Remediation for Cocaine Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01393457
First received: July 11, 2011
Last updated: February 14, 2012
Last verified: February 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Cocaine use [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Use of cocaine based on self-report and urine drug screen


Secondary Outcome Measures:
  • Cognitive function [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Performance on behavioral laboratory tasks measuring cognitive function (e.g., impulsvity, decision-making, motivation, attentional bias).


Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393457

Contacts
Contact: Fallon Brewer, BS 7134862800 Fallon.Brewer@uth.tmc.edu
Contact: Ann Garcia, RN 7134862800 Ann.Garcia@uth.tmc.edu

Locations
United States, Texas
Behavioral and Biomedical Sciences Building Recruiting
Houston, Texas, United States, 77045
Contact: Joy Schmitz, PhD    713-486-2867    Joy.M.Schmitz@uth.tmc.edu   
Contact: Stephanie Lionberger, MBA    7134862867    Stephanie.J.Lionberger@uth.tmc.edu   
Principal Investigator: Joy M Schmitz, Ph.D.         
Principal Investigator: Scott Lane, PHD         
Sub-Investigator: Frederick G Moeller, MD         
Sub-Investigator: Charles Green, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
  More Information

Additional Information:
No publications provided

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
Study First Received: July 11, 2011
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Carbidopa
Levodopa
Ropinirole
Cocaine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Agonists

ClinicalTrials.gov processed this record on August 28, 2014