Bupropion-Enhanced Contingency Management (CM) for Cocaine Dependence

• Status: Completed
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This project will examine effects of bupropion extended release (XL) at a dose of 300mg/day for cocaine abstinence among persons receiving methadone for the treatment of opioid use disorder. Participants also earned financial incentives for providing urine samples that tested negative for cocaine. Bupropion was examined for this purpose because of its previously demonstrated efficacy and safety as well as its pharmacological actions at dopamine systems. Participants were randomly assigned to bupropion XL vs. placebo and received different incentive schedules depending on whether they demonstrated abstinence from cocaine early in the study. Outcomes were tracked over a 6-month time frame and the overarching hypothesis was that bupropion (as compared to placebo) would increase the number of urine samples testing negative for cocaine, independent of whether participants demonstrated abstinence from cocaine early in the study.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Bupropion; Cocaine

Criteria

Inclusion Criteria:

• Enrolled in methadone maintenance

• Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM V) criteria for active cocaine use

• Submits one cocaine positive urine sample within 30 days of study start

• Agrees to study procedures

Exclusion Criteria:

• Healthy and without contra-indications to study medication

• Any history of epilepsy or seizure, including alcohol-, sedative-, or cocaine-related seizure

• Any increased risk of seizure such as serious head trauma with a loss of consciousness of more than an hour duration, brain tumor, or other brain pathology increasing risk of seizure.

• Current eating disorder including anorexia or bulimia

• Current use (last 30 days) of antidepressants, antipsychotics, theophyllines, systemic steroids, monoamine oxidase (MAO-A) inhibitors.

• Recent use (last 30 days) of budeprion, zyban®, wellbutrin®, aplenzin®, or any other medication containing bupropion.

• Allergy to bupropion or budeprion

• Liver enzymes greater than 3x ULN (upper limit of normal)

• Uncontrolled diabetes mellitus, or h/o diabetic coma

• Uncontrolled hypertension with BP > 140/90.

• Current psychiatric diagnosis: schizophrenia, psychosis, major depression, mania, current suicidal ideation as determined by MINI psychiatric interview, cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires

• Severe renal insufficiency (eGFR < 30 ml/min)

• Pregnancy or current breast feeding,

• Medical illness that in the view of the investigators would compromise participation in research, such as uncompensated congestive heart failure, recent history of myocardial infarction (<1year), or urologic conditions that inhibit urine collection.

• Advanced HIV infection requiring the use of HAART (Highly Active Anti-Retroviral Therapy), or with CD4 T cell count < 200/uL