Trial Outcomes & Findings for An Assessment of the Safety of Varenicline in Methamphetamine-dependent Volunteers (NCT NCT00713479)
NCT ID: NCT00713479
Last Updated: 2018-03-13
Results Overview
Systolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
15 minute intervals
Results posted on
2018-03-13
Participant Flow
Subject were recruited from local advertisements for non-treatment seeking methamphetamine users in 2008.
Participants had 30 days in which to complete all eligibility procedures. Volunteers were: MA dependent who were not seeking treatment;nicotine dependent (smoking 10+ cigarettes/day);reported using MA via smoking or IV;could not have significant medical illnesses;be taking psychotropic medications or dependence criteria for other substances.
Participant milestones
| Measure |
Placebo, Then Varenicline
Placebo drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the varenicline condition is started. Varenicline is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
|
Varenicline, Then Placebo
Varenicline dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the placebo condition is started. Placebo is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
|
|---|---|---|
|
First Medication Condition
STARTED
|
6
|
6
|
|
First Medication Condition
COMPLETED
|
2
|
6
|
|
First Medication Condition
NOT COMPLETED
|
4
|
0
|
|
Washout
STARTED
|
2
|
6
|
|
Washout
COMPLETED
|
2
|
6
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Next Medication Condition
STARTED
|
2
|
6
|
|
Next Medication Condition
COMPLETED
|
2
|
6
|
|
Next Medication Condition
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Assessment of the Safety of Varenicline in Methamphetamine-dependent Volunteers
Baseline characteristics by cohort
| Measure |
Total Sample
n=8 Participants
Includes only subjects who completed both components of the trial.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 2.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 15 minute intervalsPopulation: Per protocol
Systolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.
Outcome measures
| Measure |
Sugar Pill
n=80 time points
Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
|
Varenicline
n=80 time points
Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)
|
|---|---|---|
|
Systolic Blood Pressure
|
126.4 mm Hg
Standard Deviation 12.1
|
127.4 mm Hg
Standard Deviation 8
|
PRIMARY outcome
Timeframe: 15 minute intervalsDiastolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.
Outcome measures
| Measure |
Sugar Pill
n=80 Time Points
Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
|
Varenicline
n=80 Time Points
Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)
|
|---|---|---|
|
Diastolic Blood Pressure
|
72.4 mm Hg
Standard Deviation 6.6
|
71.7 mm Hg
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: 15 minute intervalsHeart rate is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.
Outcome measures
| Measure |
Sugar Pill
n=80 Time Points
Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
|
Varenicline
n=80 Time Points
Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)
|
|---|---|---|
|
Heart Rate
|
80.4 bpm
Standard Deviation 8.8
|
84.4 bpm
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: DailyUsing the Beck Depression Index (BDI-II), depression was assessed on a daily basis. The daily mean score during the medication intervention period is presented, with a lower score indicating lower reported depression. The scores range from 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression.
Outcome measures
| Measure |
Sugar Pill
n=64 Total BDI
Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
|
Varenicline
n=64 Total BDI
Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)
|
|---|---|---|
|
Depression
|
2.3 units on a scale
Standard Deviation 2.5
|
2.5 units on a scale
Standard Deviation 3.3
|
Adverse Events
Sugar Pill
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Varenicline
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sugar Pill
n=8 participants at risk
Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
|
Varenicline
n=8 participants at risk
Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)
|
|---|---|---|
|
Nervous system disorders
Insomnia
|
50.0%
4/8 • Number of events 4
|
75.0%
6/8 • Number of events 6
|
|
Nervous system disorders
Headache
|
0.00%
0/8
|
37.5%
3/8 • Number of events 3
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Asymptomatic PVCs
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Flu-like Symptoms
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
|
General disorders
Depressed Mood
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
Additional Information
Dr Edythe London
University of California, Los Angeles
Phone: (310) 825-0606
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place