A Phase 2 interventional study of Bupropion and Placebo in Methamphetamine Dependence, sponsored by National Institute on Drug Abuse (NIDA). Completed at 12 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-21.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 2, Interventional, and Treatment
This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.
The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the success or failure to achieve abstinence (confirmed by at least two methamphetaminenegative urines and no methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for subjects using methamphetamine 18 or less days during the 30 days prior to signing consent, assessing the safety of bupropion in this study population, assessing other measures of efficacy of bupropion in reducing methamphetamine use or craving, and other psychological assessments of methamphetamine dependence.
It is hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines and no methamphetaminepositive urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users.
National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Drug: Bupropion
Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Other: Placebo
150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
Placebo
Number of Subjects Showing Abstinence
The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.
Time frame: Weeks 11 and 12
Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use
The study population for this outcome measure is defined as those participants with methamphetamine dependence who report using methamphetamine 18 or less days during the 30 days prior to signing consent.
Time frame: 30 days
| Milestone | Bupropion | Placebo |
|---|---|---|
| Started | 100 | 104 |
| Completed | 68 | 64 |
| Not completed | 32 | 40 |
The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.
| Participants | Bupropion | Placebo |
|---|---|---|
| Number of Subjects Showing Abstinence | 14 | 20 |
The study population for this outcome measure is defined as those participants with methamphetamine dependence who report using methamphetamine 18 or less days during the 30 days prior to signing consent.
| Participants | Bupropion | Placebo |
|---|---|---|
| Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use | 65 | 76 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bupropion | — | 1/100 (1%) | 83/100 (83%) |
| Placebo | — | 3/104 (2.9%) | 93/104 (89.4%) |
| Event | Bupropion | Placebo |
|---|---|---|
| Gastric bypassGastrointestinal disorders | 1/100 | 3/104 |
| Event | Bupropion | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 37/100 | 43/104 |
| NauseaGastrointestinal disorders | 9/100 | 23/104 |
| Back PainMusculoskeletal and connective tissue disorders | 18/100 | 11/104 |
| CoughRespiratory, thoracic and mediastinal disorders | 16/100 | 14/104 |
| NasopharyngitisInfections and infestations | 4/100 | 12/104 |
| Age, Categorical(Participants) | Bupropion | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 100 | 104 | 204 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Bupropion | Placebo | Total |
|---|---|---|---|
| Female | 37 | 35 | 72 |
| Male | 63 | 69 | 132 |
| Region of Enrollment(participants) | Bupropion | Placebo | Total |
|---|---|---|---|
| United States | 100 | 105 | 205 |
Plan to share: No
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Abuse (NIDA)