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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

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 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


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




Primary Outcome Measures :
  1. 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 :
  1. Number of Participants Who Completed the 10 Week Trial [ Time Frame: 10 weeks ]


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

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
  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


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 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:
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