Bupropion-Enhanced Contingency Management (CM) for Cocaine Dependence

NCT02111798 | Completed Phase 2 Results DMC

• 3 other identifiers: NA_00090062DA034-047R01DA034047
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Substance Abuse; Cocaine Dependence

Keywords

substance abuse treatment; cocaine dependence; contingency management; abstinence incentives; medication-enhanced behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Number of Cocaine Negative Urines

  Comparison of the number of thrice-weekly urine tests submitted during weeks study 7-30 negative for cocaine for persons randomly assigned to receive placebo or bupropion XL during weeks 7-30; excused samples are omitted and missing samples are treated as positive.

  Weeks 7-30

Secondary Outcomes (1)

• Longest Consecutive Period of Negative Urine Samples

  Weeks 7-30

Study Arms (4)

Placebo/Abstinence Initiation

PLACEBO COMPARATOR

In week 2 participants will randomly assigned to receive twice daily capsules filled with placebo powder. At the end of week 6, participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial will be assigned to the Abstinence Initiation incentive arm.

Drug: Placebo; Behavioral: Abstinence Initiation

Bupropion XL/Abstinence Initiation

ACTIVE COMPARATOR

In week 2 participants will randomly assigned to receive bupropion 150mg capsules filled with placebo powder. At the end of week 6, participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial will be assigned to the Abstinence Initiation incentive arm.

Drug: Bupropion XL; Behavioral: Abstinence Initiation

Placebo/Relapse Prevention

PLACEBO COMPARATOR

In week 2 participants will randomly assigned to receive twice daily capsules filled with placebo powder. At the end of week 6, participants who did provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial will be assigned to the Abstinence Initiation incentive arm.

Drug: Placebo; Behavioral: Relapse Prevention

Bupropion XL/Relapse Prevention

ACTIVE COMPARATOR

In week 2 participants will randomly assigned to receive bupropion 150mg capsules filled with placebo powder. At the end of week 6, participants who did provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial will be assigned to the Abstinence Initiation incentive arm.

Drug: Bupropion XL; Behavioral: Relapse Prevention

Interventions

Placebo DRUG

Participants will be randomly assigned to receive placebo powder in twice-daily capsules at the end of week 2.

Placebo/Abstinence Initiation; Placebo/Relapse Prevention

Bupropion XL DRUG

Participants will be randomly assigned to receive bupropion XL 150mg/day in twice-daily capsules at the end of week 2.

Bupropion XL/Abstinence Initiation; Bupropion XL/Relapse Prevention

Abstinence Initiation BEHAVIORAL

Participants will provide urine samples thrice weekly during weeks 1-6 of the study. Urine samples will be tested immediately onsite for evidence of recent cocaine exposure. Participants who do not provide 3 urine samples that test negative for cocaine by the end of week 6 will be assigned to an Abstinence Incentive condition.

Bupropion XL/Abstinence Initiation; Placebo/Abstinence Initiation

Relapse Prevention BEHAVIORAL

Participants will provide urine samples thrice weekly during weeks 1-6 of the study. Urine samples will be tested immediately onsite for evidence of recent cocaine exposure. Participants who provide 3 urine samples that test negative for cocaine will be promptly assigned to a Relapse Prevention incentive condition.

Bupropion XL/Relapse Prevention; Placebo/Relapse Prevention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

Institute for Behavioral Resources

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Ware OD, Sweeney MM, Cunningham C, Umbricht A, Stitzer M, Dunn KE. Bupropion Slow Release vs Placebo With Adaptive Incentives for Cocaine Use Disorder in Persons Receiving Methadone for Opioid Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e232278. doi: 10.1001/jamanetworkopen.2023.2278.

  PMID: 36920397 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Cocaine-Related Disorders

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Kelly Dunn, Ph.D., MBA
• Organization: Johns Hopkins University School of Medicine

kdunn9@jhmi.edu

410-550-2254

Study Officials

• Kelly Dunn, Ph.D., MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 11, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 27, 2025
• Results First Posted: September 20, 2021

Record last verified: 2025-02

Locations

US (2)