Skip to main content
Clinical Trials/NCT01393457
NCT01393457
Completed
Phase 2

Cognitive-enhancing DA Medications for Cocaine Dependence

The University of Texas Health Science Center, Houston1 site in 1 country119 target enrollmentJune 2011

Overview

Phase
Phase 2
Intervention
levodopa/carbidopa
Conditions
Cocaine Dependence
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
119
Locations
1
Primary Endpoint
Cocaine Use Based on Urine Drug Screening
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
February 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joy Schmitz

Professor - Psychiatry

The University of Texas Health Science Center, Houston

Eligibility 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

Arms & Interventions

ldopa + ropinirole low dose

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

Intervention: levodopa/carbidopa

ldopa + ropinirole low dose

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

Intervention: Ropinirole 2 mg/d

ldopa + ropinirole high dose

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

Intervention: levodopa/carbidopa

ldopa + ropinirole high dose

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

Intervention: Ropinirole 4 mg/d

ldopa

levodopa/carbidopa 800/200 mg/d

Intervention: levodopa/carbidopa

placebo

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

  • Number of Participants Who Completed the 10 Week Trial(10 weeks)

Study Sites (1)

Loading locations...

Similar Trials