Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
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| ClinicalTrials.gov Identifier: NCT00687713 |
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Recruitment Status
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Completed
First Posted
: June 2, 2008
Results First Posted
: February 15, 2017
Last Update Posted
: March 21, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Methamphetamine Dependence | Drug: Bupropion Other: Placebo | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | May 2011 |
| Actual Study Completion Date : | May 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Bupropion
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.
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Drug: Bupropion
150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
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Placebo Comparator: Placebo
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.
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Other: Placebo
Placebo
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- Number of Subjects Showing Abstinence [ Time Frame: 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.
- Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
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): NCT00687713
| United States, California | |
| UCLA Integrated Substance Abuse Program | |
| Los Angeles, California, United States, 90025 | |
| South Bay Treatment Center | |
| San Diego, California, United States, 92115 | |
| Addiction and Pharmacology Research Laboratory | |
| San Francisco, California, United States, 94110 | |
| Friends Research Institute | |
| Torrance, California, United States, 90502 | |
| Matrix Institute | |
| Woodland Hills, California, United States, 91364 | |
| United States, Hawaii | |
| Pacific Addiction Research Center - U of Hawaii | |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Iowa | |
| Iowa Luther Hospital | |
| Des Moines, Iowa, United States, 50316 | |
| United States, Missouri | |
| U of Kansas Medical Center | |
| Kansas City, Missouri, United States, 64131 | |
| United States, New York | |
| New York University | |
| New York, New York, United States, 10010 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| University of Texas Health Science At San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| United States, Utah | |
| VA Salt Lake City Health Care System | |
| Salt Lake City, Utah, United States, 84148 | |
| Study Chair: | Jurij Mojsiak | National Institute on Drug Abuse (NIDA) |
Publications:
| Responsible Party: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00687713 History of Changes |
| Other Study ID Numbers: |
MDS Bupropion Meth 0001 |
| First Posted: | June 2, 2008 Key Record Dates |
| Results First Posted: | February 15, 2017 |
| Last Update Posted: | March 21, 2017 |
| Last Verified: | February 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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Bupropion Methamphetamine 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 Central Nervous System Stimulants Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic Agents Adrenergic Uptake Inhibitors |