Trial Outcomes & Findings for Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence (NCT NCT00687713)

NCT ID: NCT00687713

Last Updated: 2017-03-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 200 participants
• Primary outcome timeframe: Weeks 11 and 12
• Results posted on: 2017-03-21

Participant Flow

Participant milestones

Measure	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.	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
Overall Study STARTED	100	104
Overall Study COMPLETED	68	64
Overall Study NOT COMPLETED	32	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bupropion n=100 Participants 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.	Placebo n=104 Participants 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 n=204 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	104 Participants n=7 Participants	204 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	69 Participants n=7 Participants	132 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	105 participants n=7 Participants	205 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Bupropion n=100 Participants 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.	Placebo n=104 Participants 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
Number of Subjects Showing Abstinence	14 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bupropion n=100 Participants 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.	Placebo n=104 Participants 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
Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use	65 Participants	76 Participants

Adverse Events

Bupropion

Serious events: 1 serious events

Other events: 83 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bupropion n=100 participants at risk 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.	Placebo n=104 participants at risk 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
Gastrointestinal disorders Gastric bypass	1.0% 1/100	2.9% 3/104

Other adverse events

Measure	Bupropion n=100 participants at risk 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.	Placebo n=104 participants at risk 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
Gastrointestinal disorders Nausea	9.0% 9/100 • Number of events 14	22.1% 23/104 • Number of events 27
Nervous system disorders Headache	37.0% 37/100 • Number of events 68	41.3% 43/104 • Number of events 88
Infections and infestations Nasopharyngitis	4.0% 4/100 • Number of events 5	11.5% 12/104 • Number of events 12
Musculoskeletal and connective tissue disorders Back Pain	18.0% 18/100 • Number of events 19	10.6% 11/104 • Number of events 13
Respiratory, thoracic and mediastinal disorders Cough	16.0% 16/100 • Number of events 17	13.5% 14/104 • Number of events 17

Additional Information

Ann Anderson, MD

National Institute on Drug Abuse

Phone: 301-827-5916

Email: aanderso@nida.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place