Trial Outcomes & Findings for Varenicline for Methamphetamine Dependence (NCT NCT01365819)

NCT ID: NCT01365819

Last Updated: 2018-01-18

Results Overview

The primary analysis will compare two weeks continuous MA abstinence at end of treatment during weeks 8 and 9 among participants randomly assigned to receive varenicline versus those randomly assigned to receive placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: 9 weeks
• Results posted on: 2018-01-18

Participant Flow

Participant milestones

Measure	Sugar Pill Placebo Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).	Varenicline Varenicline (Chantix (R)) Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).
Overall Study STARTED	25	27
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	13	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Varenicline for Methamphetamine Dependence

Baseline characteristics by cohort

Measure	Sugar Pill n=25 Participants Placebo Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).	Varenicline n=27 Participants Varenicline (Chantix (R)) Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).	Total n=52 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	25 Participants n=5 Participants	27 Participants n=7 Participants	52 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	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 weeks

The primary analysis will compare two weeks continuous MA abstinence at end of treatment during weeks 8 and 9 among participants randomly assigned to receive varenicline versus those randomly assigned to receive placebo.

Outcome measures

Measure	Sugar Pill n=25 Participants Placebo Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).	Varenicline n=27 Participants Varenicline (Chantix (R)) Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).
End of Treatment Abstinence	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 9 weeks

Population: This outcome was not assessed.

Secondary aims will compare treatment retention among participants randomly assigned to receive varenicline or placebo

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 weeks

Population: This analysis presents the number of participants in each condition who achieved abstinence during treatment and later relapsed.

1) The number of participants who achieve MA abstinence and subsequently relapse to MA use during treatment by condition (varenicline, placebo) during the outpatient treatment period.

Outcome measures

Measure	Sugar Pill n=14 Participants Placebo Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).	Varenicline n=13 Participants Varenicline (Chantix (R)) Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).
Prevalence of Relapse Following Initiation of Abstinence During Treatment	6 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 weeks

Population: This outcome was not assessed.

2) To determine whether varenicline reduces MA withdrawal symptoms more than placebo among MA- dependent participants over the course of the trial.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 weeks

Population: This analysis includes a sub-population of participants in both conditions who smoked any cigarettes during treatment. Results are model fitted number of cigarettes smoked per week at baseline and at week 9.

3) To determine whether varenicline reduces cigarette smoking more than placebo among cigarette smoking MA dependent participants.

Outcome measures

Measure	Sugar Pill n=37 average number of cigarettes Placebo Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).	Varenicline n=42 average number of cigarettes Varenicline (Chantix (R)) Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).
Reduction in Cigarette Smoking	19 average number of cigarettes Standard Deviation 20	1 average number of cigarettes Standard Deviation 3

Adverse Events

Sugar Pill

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Varenicline

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sugar Pill n=25 participants at risk Placebo Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).	Varenicline n=27 participants at risk Varenicline (Chantix (R)) Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).
Nervous system disorders Headache	28.0% 7/25 • Number of events 9 • Adverse event data were collected during the course of the clinical trial, which included 2 weeks of screening, 9 weeks of medication and 4 weeks of follow-up.	37.0% 10/27 • Number of events 15 • Adverse event data were collected during the course of the clinical trial, which included 2 weeks of screening, 9 weeks of medication and 4 weeks of follow-up.
Psychiatric disorders Insomnia	20.0% 5/25 • Number of events 7 • Adverse event data were collected during the course of the clinical trial, which included 2 weeks of screening, 9 weeks of medication and 4 weeks of follow-up.	33.3% 9/27 • Number of events 11 • Adverse event data were collected during the course of the clinical trial, which included 2 weeks of screening, 9 weeks of medication and 4 weeks of follow-up.
Psychiatric disorders Vivid dreams	20.0% 5/25 • Number of events 7 • Adverse event data were collected during the course of the clinical trial, which included 2 weeks of screening, 9 weeks of medication and 4 weeks of follow-up.	44.4% 12/27 • Number of events 15 • Adverse event data were collected during the course of the clinical trial, which included 2 weeks of screening, 9 weeks of medication and 4 weeks of follow-up.
Gastrointestinal disorders Nausea	20.0% 5/25 • Number of events 6 • Adverse event data were collected during the course of the clinical trial, which included 2 weeks of screening, 9 weeks of medication and 4 weeks of follow-up.	37.0% 10/27 • Number of events 13 • Adverse event data were collected during the course of the clinical trial, which included 2 weeks of screening, 9 weeks of medication and 4 weeks of follow-up.

Additional Information

Dr. Steve Shoptaw

UCLA, Dept of Family Medicine

Phone: 310-794-0619

Email: sshoptaw@mednet.ucla.edu

Results disclosure agreements

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