Striatal Effective Connectivity to Predict Treatment Response in Cocaine Misuse
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: levodopa/carbidopa 400/100 BID
Intervention description: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.
Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
Intervention MeSH terms: Levodopa; Carbidopa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: drug abuse; cocaine; impulsivity; dopamine

Summary:

      This project proposes to investigate the role of brain connectivity in the mechanism of
      treatment response to dopaminergic medications in cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects

          -  Age 18 to 50

          -  Meet current DSM-IV criteria for cocaine dependence who are seeking treatment.

        Exclusion Criteria:

          1. Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine,
             marijuana, nicotine, or alcohol

          2. Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder
             requiring ongoing treatment and/or making study participation unsafe

          3. Significant current suicidal or homicidal ideation

          4. Medical conditions contraindicating levodopa/carbidopa or pharmacotherapy (e.g.,
             evidence of any movement disorder, clinically significant pulmonary disease,
             cardiovascular disease, liver or kidney disease, seizure disorder)

          5. Taking CNS active concomitant medications

          6. Taking medications known to have significant drug interactions with the study
             medication (e.g., CYP P-450-2D6 inhibitors, such as tamoxifen, iron salts, pyridoxine,
             monoamine oxidase inhibitors, phenothiazines, selegiline, anesthetics)

          7. Having conditions of probation or parole requiring reports of drug use to officers of
             the court

          8. Impending incarceration

          9. Pregnant or breast feeding for female patients

         10. Inability to read, write, or speak English

         11. Having plans to leave the immediate geographical area within 3 months

         12. Unwillingness or not competent to sign a written informed consent form

         13. Individuals who have pacemakers, metal or electromechanical implants or metallic
             foreign bodies

         14. Patients who are known to be HIV positive will not be included due to possible CNS
             effects of HIV.

         15. Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal
             symptoms