Recruitment

Recruitment Status
Completed
Estimated Enrollment
200

Inclusion Criterias

Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM V) criteria for active cocaine use
Agrees to study procedures
Submits one cocaine positive urine sample within 30 days of study start
...
Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM V) criteria for active cocaine use
Agrees to study procedures
Submits one cocaine positive urine sample within 30 days of study start
Enrolled in methadone maintenance

Exclusion Criterias

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)
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.
...
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)
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.
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 use (last 30 days) of antidepressants, antipsychotics, theophyllines, systemic steroids, monoamine oxidase (MAO-A) inhibitors.
Allergy to bupropion or budeprion
Pregnancy or current breast feeding,
Recent use (last 30 days) of budeprion, zyban®, wellbutrin®, aplenzin®, or any other medication containing bupropion.
Any history of epilepsy or seizure, including alcohol-, sedative-, or cocaine-related seizure
Uncontrolled diabetes mellitus, or h/o diabetic coma
Advanced HIV infection requiring the use of HAART (Highly Active Anti-Retroviral Therapy), or with CD4 T cell count < 200/uL
Uncontrolled hypertension with BP > 140/90.
Liver enzymes greater than 3x ULN (upper limit of normal)
Healthy and without contra-indications to study medication
Current eating disorder including anorexia or bulimia

Summary

Conditions
  • Cocaine Dependence
  • Substance Abuse
Type
Interventional
Phase
Phase 2 & Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

The efficacy of behavior therapies may be enhanced by certain medications, particularly those that act on dopaminergic systems. The purpose of this project is to examine effects of bupropion on initiation and maintenance of cocaine abstinence in a population of cocaine dependent methadone maintenanc...

The efficacy of behavior therapies may be enhanced by certain medications, particularly those that act on dopaminergic systems. The purpose of this project is to examine effects of bupropion on initiation and maintenance of cocaine abstinence in a population of cocaine dependent methadone maintenance patients. Bupropion appears to be the most promising medication for this purpose because of its previously demonstrated efficacy and safety as well as its pharmacological actions at dopamine systems. Methadone maintained cocaine dependent patients will participate (N = 200). Volunteers will be eligible for inclusion in the study if they are 1) enrolled in methadone maintenance treatment, having previously met the criteria for opioid dependence; 2) between the ages of 18 and 65; 3) provide evidence of cocaine dependence (DSM-IV criteria, self-report, and/or urine tests positive for cocaine during the intake process); and 4) are willing to take study medications and adhere to reporting and data collection schedules. Exclusion Criteria are: 1) history of epilepsy or seizure, including alcohol- or cocaine-related seizure; 2) conditions with increased risk of seizure (e.g. head trauma with loss of consciousness > 30 mins), 3) current use (past 30 days) of antidepressants, antipsychotics, theophyllines, systemic steroids, MAO-A inhibitors, 4) recent use (past 30 days of any medication containing bupropion or budeprion (Wellbutrin®, Zyban®), 5) allergy to bupropion or budeprion, 6) liver enzyme levels greater than 3x upper limit of normal (ULN); 7) uncontrolled diabetes mellitus (glucose > 200mg%); 8) severe psychiatric diagnosis: schizophrenia, psychosis, major depression, mania, current suicidal ideation with plan; cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires; 9) severe renal insufficiency (eGFR < 30 ml/min), 10) pregnant, breast feeding or unwilling to use birth control, 11) medical illness that in the view of the investigators would compromise participation in research, 12) advanced HIV infection requiring HAART 13) current eating disorder (anorexia or bulimia), 14) uncontrolled hypertension with blood pressure ( BP) >140/90. Study participants who qualify and sign informed consent will be stratified according to their initial response to an abstinence incentive (contingency management) procedure targeting cocaine negative urines. Those who stop their cocaine use will enter a study that examines effects of bupropion XL (300mg/day) versus placebo on relapse prevention. Those who fail to stop cocaine use after initial exposure to the CM procedure will enter a parallel study conducted concurrently that examines the effects of bupropion XL (300mg/day) on abstinence initiation. Our 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. Each study will involve a CM schedule that is uniquely tailored to the questions being asked but that is equated on total amount that can be earned ($675). Both studies will track outcomes over a 6-month time frame that includes assessment of drug use outcomes 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 hypothesize that bupropion compared to placebo participants will report non-drug activities as more pleasurable (reinforcing), will engage in more of them and that measures of non-drug reinforcement will mediate abstinence outcomes. Overall, this research will provide new and valuable information about combined behavioral-pharmacological treatments and specifically the conditions under which medication may enhance effects of CM. If hypothesized synergies can be demonstrated, the study will point the way to a significant advance in improved treatment outcomes for this critical group of drug abusers. The proposed study is compelling because it conceptually differentiates the two key clinical issues in treatment of stimulant abusers- abstinence initiation and relapse prevention. It uses a design that efficiently and effectively tests a combined treatment approach for each clinical issue and as well examines cognitive function and reinforcement-based mediators. The research will add to understanding of the interplay between brain reinforcement systems and drug-seeking behavior. Finally, it will make an important contribution to behavioral therapy development by exploring a novel solution to limitations previously noted for CM that include lack of response in some patients and relapse after withdrawal of incentives.

Inclusion Criterias

Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM V) criteria for active cocaine use
Agrees to study procedures
Submits one cocaine positive urine sample within 30 days of study start
...
Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM V) criteria for active cocaine use
Agrees to study procedures
Submits one cocaine positive urine sample within 30 days of study start
Enrolled in methadone maintenance

Exclusion Criterias

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)
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.
...
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)
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.
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 use (last 30 days) of antidepressants, antipsychotics, theophyllines, systemic steroids, monoamine oxidase (MAO-A) inhibitors.
Allergy to bupropion or budeprion
Pregnancy or current breast feeding,
Recent use (last 30 days) of budeprion, zyban®, wellbutrin®, aplenzin®, or any other medication containing bupropion.
Any history of epilepsy or seizure, including alcohol-, sedative-, or cocaine-related seizure
Uncontrolled diabetes mellitus, or h/o diabetic coma
Advanced HIV infection requiring the use of HAART (Highly Active Anti-Retroviral Therapy), or with CD4 T cell count < 200/uL
Uncontrolled hypertension with BP > 140/90.
Liver enzymes greater than 3x ULN (upper limit of normal)
Healthy and without contra-indications to study medication
Current eating disorder including anorexia or bulimia

Locations

Baltimore, Maryland, 21224
Baltimore, Maryland, 21224
Baltimore, Maryland, 21224
Baltimore, Maryland, 21224

Tracking Information

NCT #
NCT02111798
Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
  • Principal Investigator: Kelly Dunn, Ph.D. Johns Hopkins University
  • Kelly Dunn, Ph.D. Johns Hopkins University