Trial Outcomes & Findings for Bupropion in the Treatment of Methamphetamine Dependence (NCT NCT00572234)

Results Overview

The primary outcome measure was number of days methamphetamine use/week at weeks 12 and week 24.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Assessed Methamphetamine use at weeks 12 and 24, week 24 reported

Results posted on

2023-10-10

Participant Flow

Dates of recruitment: August 31, 2007 - April 6, 2010 Recruitment from residential substance use disorder treatment programs in Omaha and Lincoln, Nebraska.

Initially participants were assigned to one of two randomization pools: one group with and one group without psychoses. However as of January 30, 2009 no participants met criteria for randomization to the psychosis arm of the study and the protocol was changed to remove the psychosis randomization pool.

Participant milestones

Participant milestones
Measure	Receiving Bupropion (Sustain Release) SR receiving bupropion SR bupropion SR: 12 week course of bupropion SR 150 mg, (twice a day) BID	Treatment as Usual Not receiving bupropion
Overall Study STARTED	19	21
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bupropion in the Treatment of Methamphetamine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Receiving Bupropion SR n=19 Participants receiving bupropion SR bupropion SR: 12 week course of bupropion SR 150 mg, BID	Treatment as Usual n=21 Participants Not receiving bupropion	Total n=40 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 10.9 • n=99 Participants	34 years STANDARD_DEVIATION 7.7 • n=107 Participants	34 years STANDARD_DEVIATION 9.3 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	10 Participants n=107 Participants	21 Participants n=206 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	11 Participants n=107 Participants	19 Participants n=206 Participants

PRIMARY outcome

Timeframe: Assessed Methamphetamine use at weeks 12 and 24, week 24 reported

Population: Analyses were per protocol and based on number of participants enrolled in study who were not withdrawn from the study.

The primary outcome measure was number of days methamphetamine use/week at weeks 12 and week 24.

Outcome measures

Outcome measures
Measure	Receiving Bupropion SR n=19 Participants receiving bupropion SR 12 week course of bupropion SR 150 mg, BID bupropion SR: 12 week course of bupropion SR 150 mg, BID	Treatment as Usual n=21 Participants Not receiving bupropion
Estimate the Treatment Effect of Bupropion for Methamphetamine (Meth) Dependence.	5.6 days Standard Deviation 1.9	6.0 days Standard Deviation 1.3

Adverse Events

Receiving Bupropion SR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Grant

University of Nebraska Medical Center

Phone: 402-995-4347

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place