Methamphetamine Dependence
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGBupropion
150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
OTHERPlacebo
Placebo
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Must have a DSM-IV diagnosis of methamphetamine dependence as determined by MINI * Must have at least 1 amphetamine or methamphetamine positive urine specimen after the start of screening and before randomization or provide information to verify recent use if a positive urine sample can't be obtained * Must report using methamphetamine for 29 days or less during the 30 day period prior signing consent using the timeline follow-back method * Must be willing and able to comply with study procedures * Must be able to verbalize and understand consent forms and provide written informed consent * Must be seeking treatment for methamphetamine dependence
Exclusion criteria
* Please contact study site for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Showing Abstinence | Weeks 11 and 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use | 30 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupropion Subjects received 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.
Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper. | 100 |
| Placebo Subjects received 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.
Placebo: Placebo | 104 |
| Total | 204 |
Baseline characteristics
| Characteristic | Bupropion | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 104 Participants | 204 Participants |
| Region of Enrollment United States | 100 participants | 105 participants | 205 participants |
| Sex: Female, Male Female | 37 Participants | 35 Participants | 72 Participants |
| Sex: Female, Male Male | 63 Participants | 69 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 83 / 100 | 93 / 104 |
| serious Total, serious adverse events | 1 / 100 | 3 / 104 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupropion | Number of Subjects Showing Abstinence | 14 Participants |
| Placebo | Number of Subjects Showing Abstinence | 20 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupropion | Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use | 65 Participants |
| Placebo | Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use | 76 Participants |