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Cognitive Remediation for Cocaine Dependence

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
levodopa/carbidopa
Ropinirole 2 mg/d
Placebo
Ropinirole 4 mg/d
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine, cognition, medication, treatment

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Behavioral and Biomedical Sciences Building

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

ldopa + ropinirole low dose

ldopa + ropinirole high dose

ldopa

placebo

Arm Description

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

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

levodopa/carbidopa 800/200 mg/d

Placebo

Outcomes

Primary Outcome Measures

Cocaine Use Based on Urine Drug Screening
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

Full Information

First Posted
July 11, 2011
Last Updated
March 23, 2018
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT01393457
Brief Title
Cognitive Remediation for Cocaine Dependence
Official Title
Cognitive-enhancing DA Medications for Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
cocaine, cognition, medication, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ldopa + ropinirole low dose
Arm Type
Active Comparator
Arm Description
levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d
Arm Title
ldopa + ropinirole high dose
Arm Type
Active Comparator
Arm Description
levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d
Arm Title
ldopa
Arm Type
Active Comparator
Arm Description
levodopa/carbidopa 800/200 mg/d
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
levodopa/carbidopa
Other Intervention Name(s)
ldopa
Intervention Description
800/200 mg/d
Intervention Type
Drug
Intervention Name(s)
Ropinirole 2 mg/d
Other Intervention Name(s)
Requip
Intervention Description
2 mg/d
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sugar pill
Intervention Type
Drug
Intervention Name(s)
Ropinirole 4 mg/d
Other Intervention Name(s)
Requip
Intervention Description
4 mg/d
Primary Outcome Measure Information:
Title
Cocaine Use Based on Urine Drug Screening
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Who Completed the 10 Week Trial
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Behavioral and Biomedical Sciences Building
City
Houston
State/Province
Texas
ZIP/Postal Code
77045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34600245
Citation
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.
Results Reference
derived

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Cognitive Remediation for Cocaine Dependence

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