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An Assessment of the Safety of Varenicline in Methamphetamine-dependent Volunteers

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ClinicalTrials.gov Identifier: NCT00713479
Recruitment Status : Completed
First Posted : July 11, 2008
Results First Posted : January 27, 2014
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steve Shoptaw, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Methamphetamine Addiction
Crystal Meth Addiction
Amphetamine Addiction
Interventions Drug: Varenicline, then placebo
Drug: Placebo, then varenicline
Enrollment 8
Recruitment Details Subject were recruited from local advertisements for non-treatment seeking methamphetamine users in 2008.
Pre-assignment Details 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.
Arm/Group Title Placebo, Then Varenicline Varenicline, Then Placebo
Hide Arm/Group Description 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 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).
Period Title: First Medication Condition
Started 6 6
Completed 2 6
Not Completed 4 0
Period Title: Washout
Started 2 6
Completed 2 6
Not Completed 0 0
Period Title: Next Medication Condition
Started 2 6
Completed 2 6
Not Completed 0 0
Arm/Group Title Total Sample
Hide Arm/Group Description Includes only subjects who completed both components of the trial.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
This is a crossover design wherein each subject completed both the sugar pill treatment condition and the varenicline(medication under study) condition. Two subjects in the placebo condition did not complete the first component of the trial.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
39.3  (2.1)
[1]
Measure Description: This value is for subjects completing both arms of the trial (n=8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
2
  25.0%
Male
6
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Systolic Blood Pressure
Hide Description 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.
Time Frame 15 minute intervals
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Sugar Pill Varenicline
Hide Arm/Group Description:

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).

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)

Overall Number of Participants Analyzed 8 8
Overall Number of Units Analyzed
Type of Units Analyzed: Time points
80 80
Mean (Standard Deviation)
Unit of Measure: mm Hg
126.4  (12.1) 127.4  (8)
2.Primary Outcome
Title Diastolic Blood Pressure
Hide Description Diastolic 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.
Time Frame 15 minute intervals
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill Varenicline
Hide Arm/Group Description:

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.

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).

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.

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).

Overall Number of Participants Analyzed 8 8
Overall Number of Units Analyzed
Type of Units Analyzed: Time Points
80 80
Mean (Standard Deviation)
Unit of Measure: mm Hg
72.4  (6.6) 71.7  (4.3)
3.Primary Outcome
Title Heart Rate
Hide Description Heart 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.
Time Frame 15 minute intervals
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill Varenicline
Hide Arm/Group Description:

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.

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).

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.

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).

Overall Number of Participants Analyzed 8 8
Overall Number of Units Analyzed
Type of Units Analyzed: Time Points
80 80
Mean (Standard Deviation)
Unit of Measure: bpm
80.4  (8.8) 84.4  (9.3)
4.Secondary Outcome
Title Depression
Hide Description Using 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.
Time Frame Daily
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill Varenicline
Hide Arm/Group Description:

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.

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).

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.

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).

Overall Number of Participants Analyzed 8 8
Overall Number of Units Analyzed
Type of Units Analyzed: Total BDI
64 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (2.5) 2.5  (3.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugar Pill Varenicline
Hide Arm/Group Description

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).

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)

All-Cause Mortality
Sugar Pill Varenicline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Pill Varenicline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sugar Pill Varenicline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/8 (75.00%)      7/8 (87.50%)    
Cardiac disorders     
Tachycardia   1/8 (12.50%)  1 0/8 (0.00%)  0
Asymptomatic PVCs   0/8 (0.00%)  0 1/8 (12.50%)  1
Gastrointestinal disorders     
Nausea   0/8 (0.00%)  0 1/8 (12.50%)  1
Diarrhea   1/8 (12.50%)  1 0/8 (0.00%)  0
Constipation   2/8 (25.00%)  2 0/8 (0.00%)  0
General disorders     
Flu-like Symptoms   1/8 (12.50%)  1 0/8 (0.00%)  0
Depressed Mood   0/8 (0.00%)  0 1/8 (12.50%)  1
Nervous system disorders     
Insomnia   4/8 (50.00%)  4 6/8 (75.00%)  6
Headache   0/8 (0.00%)  0 3/8 (37.50%)  3
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Edythe London
Organization: University of California, Los Angeles
Phone: (310) 825-0606
Responsible Party: Steve Shoptaw, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00713479     History of Changes
Other Study ID Numbers: 18185-PI-EDL-V
P50DA018185 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIH / NIDA )
First Submitted: July 10, 2008
First Posted: July 11, 2008
Results First Submitted: March 26, 2013
Results First Posted: January 27, 2014
Last Update Posted: March 13, 2018