Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00687713
• Collaborator: (none)
• Enrollment: 200
• Locations: 12
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence	Drug: Bupropion; Other: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• 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 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Bupropion; 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
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.	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Integrated Substance Abuse Program	Los Angeles	California	United States	90025
2	South Bay Treatment Center	San Diego	California	United States	92115
3	Addiction and Pharmacology Research Laboratory	San Francisco	California	United States	94110
4	Friends Research Institute	Torrance	California	United States	90502
5	Matrix Institute	Woodland Hills	California	United States	91364
6	Pacific Addiction Research Center - U of Hawaii	Honolulu	Hawaii	United States	96817
7	Iowa Luther Hospital	Des Moines	Iowa	United States	50316
8	U of Kansas Medical Center	Kansas City	Missouri	United States	64131
9	New York University	New York	New York	United States	10010
10	Medical University of South Carolina	Charleston	South Carolina	United States	29425
11	University of Texas Health Science At San Antonio	San Antonio	Texas	United States	78229-3900
12	VA Salt Lake City Health Care System	Salt Lake City	Utah	United States	84148

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)

Investigators

• Study Chair: Jurij Mojsiak, National Institute on Drug Abuse (NIDA)

Study Documents (Full-Text)

None provided.

More Information

Publications

• Anderson AL, Li SH, Markova D, Holmes TH, Chiang N, Kahn R, Campbell J, Dickerson DL, Galloway GP, Haning W, Roache JD, Stock C, Elkashef AM. Bupropion for the treatment of methamphetamine dependence in non-daily users: a randomized, double-blind, placebo-controlled trial. Drug Alcohol Depend. 2015 May 1;150:170-4. doi: 10.1016/j.drugalcdep.2015.01.036. Epub 2015 Feb 7.

• Responsible Party: National Institute on Drug Abuse (NIDA)
• ClinicalTrials.gov Identifier: NCT00687713
• Other Study ID Numbers: MDS Bupropion Meth 0001
• First Posted: Jun 2, 2008
• Last Update Posted: Mar 21, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Bupropion

Study Results

Participant Flow

Arm/Group Title	Bupropion	Placebo
Arm/Group Description	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.	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
Period Title: Overall Study
STARTED	100	104
COMPLETED	68	64
NOT COMPLETED	32	40

Baseline Characteristics

Arm/Group Title	Bupropion	Placebo	Total
Arm/Group Description	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.	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	Total of all reporting groups
Overall Participants	100	104	204
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	100 100%	104 100%	204 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	37 37%	35 33.7%	72 35.3%
Male	63 63%	69 66.3%	132 64.7%
Region of Enrollment (participants) [Number]
United States	100 100%	105 101%	205 100.5%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Showing Abstinence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupropion	Placebo
Arm/Group Description	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.	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
Measure Participants	100	104
Count of Participants [Participants]	14 14%	20 19.2%

2. Secondary Outcome

Title	Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupropion	Placebo
Arm/Group Description	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. Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.	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. Placebo: Placebo
Measure Participants	100	104
Count of Participants [Participants]	65 65%	76 73.1%

Adverse Events

Arm/Group Title	Bupropion		Placebo
Arm/Group Description	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.		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
All Cause Mortality
	Bupropion		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bupropion		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/100 (1%)		3/104 (2.9%)
Gastrointestinal disorders
Gastric bypass	1/100 (1%)		3/104 (2.9%)
Other (Not Including Serious) Adverse Events
	Bupropion		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	83/100 (83%)		93/104 (89.4%)
Gastrointestinal disorders
Nausea	9/100 (9%)	14	23/104 (22.1%)	27
Infections and infestations
Nasopharyngitis	4/100 (4%)	5	12/104 (11.5%)	12
Musculoskeletal and connective tissue disorders
Back Pain	18/100 (18%)	19	11/104 (10.6%)	13
Nervous system disorders
Headache	37/100 (37%)	68	43/104 (41.3%)	88
Respiratory, thoracic and mediastinal disorders
Cough	16/100 (16%)	17	14/104 (13.5%)	17

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.