Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02111798 |
| Other study ID # |
NA_00090062 |
| Secondary ID |
DA034-047R01DA03 |
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
July 2014 |
| Est. completion date |
January 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 persons
being treated with methadone for the treatment of opioid use disorder who are concurrently
using cocaine. 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.
Participants 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.
They will be excluded if they have 1) a 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.
All participants will be randomly assigned to receive bupropion XL (300mg/day) or placebo. In
addition, study participants will also receive an add-on incentive-based intervention
depending upon whether they provide 6 consecutive-urine samples that test negative for
cocaine. Those who provide 6 consecutive negative urine samples will earn incentives for
continuing to provide negative sample (Relapse Prevention group) and those who do not achieve
this threshold will earn a different schedule of incentives to promote abstinence (Abstinence
Initiation). Our hypothesis is that bupropion as compared to placebo treatment will both
enhance the number of urine samples testing negative for cocaine. All participants will be
eligible to earn $675 in incentives and cocaine use will be monitored via thrice weekly urine
samples collected for a 6 month period.
Overall, this research will provide new and valuable information about the use of bupropion
XL to enhance provision of cocaine-negative urine samples in persons independent of their
early abstinence behaviors. 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.
