Cognitive Remediation for Cocaine Dependence

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Cocaine Dependence

Treatments: Drug: levodopa/carbidopa; Drug: Ropinirole 2 mg/d; Drug: Placebo; Drug: Ropinirole 4 mg/d

Study type: Interventional

Funder types: Other

Identifiers

NCT01393457

DA030787

Details and patient eligibility

About

The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.

Enrollment: 119 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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119 participants in 4 patient groups, including a placebo group

ldopa + ropinirole low dose

Active Comparator group

Description:

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

Treatment:

Drug: Ropinirole 2 mg/d

Drug: levodopa/carbidopa

ldopa + ropinirole high dose

Active Comparator group

Description:

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

Treatment:

Drug: Ropinirole 4 mg/d

Drug: levodopa/carbidopa

ldopa

Active Comparator group

Description:

levodopa/carbidopa 800/200 mg/d

Treatment:

Drug: levodopa/carbidopa

placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo