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Trial record 2 of 150 for:    cocaine OR heroin OR ecstasy | Recruiting, Not yet recruiting Studies

Bupropion-Enhanced Contingency Management (CM) for Cocaine Dependence

This study is currently recruiting participants.
Verified September 2017 by Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02111798
First Posted: April 11, 2014
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
This project will examine effects of bupropion extended release (XL) at a dose of 300mg/day on initiation and maintenance of cocaine abstinence in a population of cocaine dependent methadone maintenance patients (N = 200) who can earn financial incentives for stopping their cocaine use. Bupropion is a promising medication for this purpose because of its previously demonstrated efficacy and safety as well as its pharmacological actions at dopamine systems. The study will use a stratified randomization strategy that will allow us to separately examine bupropion effects on abstinence initiation and relapse prevention. Outcomes will be tracked over a 6-month time frame that includes assessment of drug use during and after incentives have stopped. In addition, the project will provide novel information about mechanisms of medication effects by measuring subjective drug effects, drug vs money choices, and self-reports of pleasure derived from daily non-drug activities. The investigators hypothesis is that bupropion as compared to placebo treatment will both enhance rates of abstinence initiation in those who have difficulty stopping cocaine and retard rates of relapse in those who initially stopped their cocaine use. Furthermore that bupropion compared to placebo participants will report non-drug activities as more pleasurable (reinforcing), will engage in more of them. If hypothesized synergies are demonstrated, the study will point the way to a significant advance in improved treatment strategies for this critical group of drug abusers.

Condition Intervention Phase
Substance Abuse Cocaine Dependence Drug: Bupropion XL Drug: placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupropion-Enhanced CM for Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • number of cocaine negative urines [ Time Frame: 24 week intervention ]
    Participants will be stratified early in the study based on their response to a contingency management run-in and randomized to active vs placebo medication from within these strata. Those who stop cocaine use for at least 2 weeks will be assigned to the "relapse prevention" study while those who do not meet this criteria will be assigned to "abstinence initiation" where primary endpoint is number of cocaine negative urines submitted during weeks study 7-30.


Secondary Outcome Measures:
  • latency to first cocaine positive urine [ Time Frame: Randomization through study week 30 ]
    Participants who achieve 2 weeks of cocaine abstinence during initial study weeks (4-6) will be randomized to active or placebo medication and followed for primary outcome of latency to first cocaine positive urine


Estimated Enrollment: 200
Study Start Date: July 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Participants will be randomized to receive active or placebo medication after being stratified according to their initial response to a contingency management intervention (i.e. whether or not they stop using cocaine when offered financial incentives to do so).
Drug: placebo
Cocaine dependent methadone maintenance patients will receive usual care at their methadone clinic. All study participants will be able to earn financial incentives throughout the study for stopping cocaine use. In addition, they will receive double blind medication (active vs placebo) daily at the methadone clinic. Participants will see research staff 3 times per week to deliver urine specimens and may be awarded financial incentives if these test cocaine negative.
Other Name: sugar pill
Active Comparator: Bupropion XL
Participants will be randomized to receive active or placebo medication after being stratified according to their initial response to a contingency management intervention (i.e. whether or not they stop using cocaine when offered financial incentives to do so). Active medication is bupropion XL 300mg/day.
Drug: Bupropion XL
Cocaine dependent methadone maintenance patients will receive usual care at their methadone clinic. All study participants will be able to earn financial incentives throughout the study for stopping cocaine use. In addition, they will receive double blind medication (active vs placebo) daily at the methadone clinic. Active medication is bupropion XL 300mg/day. Participants will see research staff 3 times per week to deliver urine specimens and may be awarded financial incentives if these test cocaine negative.
Other Name: Wellbutrin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111798


Contacts
Contact: Maxine Stitzer, Ph.D. 410 550-0042 mstitzer@jhmi.edu
Contact: Kelly Dunn, Ph.D. 410 550-2254 kdunn9@jhmi.edu

Locations
United States, Maryland
Behavioral Pharmacology Research Unit Recruiting
Baltimore, Maryland, United States, 21224
Contact: Maxine L Stitzer, Ph.D.    410-550-0042    mstitzer@jhmi.edu   
Contact: Kelly Dunn, Ph.D.    410 550-2254    kdunn9@jhmi.edu   
Sub-Investigator: Annie Umbricht, MD         
Sub-Investigator: Kelly Dunn, Ph.D.         
Principal Investigator: Maxine L Stitzer, Ph.D.         
Institute for Behavioral Resources Recruiting
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Maxine Stitzer, Ph.D. Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02111798     History of Changes
Other Study ID Numbers: NA00090062
DA034-047 ( Other Identifier: JHU )
First Submitted: March 28, 2014
First Posted: April 11, 2014
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Johns Hopkins University:
substance abuse treatment
cocaine dependence
contingency management; abstinence incentives
medication-enhanced behavioral therapy

Additional relevant MeSH terms:
Cocaine-Related Disorders
Cocaine
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents