Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Varenicline vs Placebo for the Treatment of Methamphetamine Dependence (RAVEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01011829
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : March 14, 2013
Last Update Posted : March 14, 2013
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: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Methamphetamine Dependence
Substance Abuse
Methamphetamine Abuse
Interventions Drug: Varenicline
Drug: Placebo
Enrollment 20
Recruitment Details Twenty treatment-seeking adults with current methamphetamine (MA) dependence were recruited through advertisements in newspapers, the internet, radio and community outreach from Nov 2009 to Feb 2010.
Pre-assignment Details All potential subjects were consented and then completed study screening measures over a max. of six study visits in order to determine study eligibility. Subjects had to be over 18 years old, MA dependent, and looking for treatment with no Axis I disorder not related to substance abuse and have no contraindications for use of varenicline.
Arm/Group Title Varenicline Placebo (Sugar Pill)
Hide Arm/Group Description 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 8). 8 weeks of daily matching oral placebo in tablet form
Period Title: Overall Study
Started 10 10
Completed 6 1
Not Completed 4 9
Arm/Group Title Varenicline Placebo (Sugar Pill) Total
Hide Arm/Group Description 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 8). 8 weeks of daily matching oral placebo in tablet form Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
37.1  (10.4) 35.1  (10.5) 36.1  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
3
  30.0%
4
  40.0%
7
  35.0%
Male
7
  70.0%
6
  60.0%
13
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo.
Hide Description Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 24 urine drug screens to provide during the 8 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.
Time Frame 8-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Varenicline Placebo (Sugar Pill)
Hide Arm/Group Description:
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 8).
8 weeks of daily matching oral placebo in tablet form
Overall Number of Participants Analyzed 10 10
Overall Number of Units Analyzed
Type of Units Analyzed: Urine drug screen results
24 24
Mean (Standard Deviation)
Unit of Measure: total MA-free urine drug screens
7.4  (10) 2.3  (4.8)
2.Secondary Outcome
Title Retention (Completion)
Hide Description Retention was determined by the proportion of participants retained for the entire trial and time until drop-out.
Time Frame 8-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Varenicline Placebo (Sugar Pill)
Hide Arm/Group Description:
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 8).
8 weeks of daily matching oral placebo in tablet form
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
6 1
Time Frame Adverse events (AEs) were assessed at each study visit during the 8 weeks of treatment and in the follow up period (4 weeks).
Adverse Event Reporting Description Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form. In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
 
Arm/Group Title Varenicline Placebo (Sugar Pill)
Hide Arm/Group Description 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 8). 8 weeks of daily matching oral placebo in tablet form
All-Cause Mortality
Varenicline Placebo (Sugar Pill)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Placebo (Sugar Pill)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline Placebo (Sugar Pill)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/10 (90.00%)      8/10 (80.00%)    
Eye disorders     
Conjunctivitis  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  4/10 (40.00%)  4 1/10 (10.00%)  1
Constipation  1  1/10 (10.00%)  1 0/10 (0.00%)  0
General disorders     
Insomnia  1  3/10 (30.00%)  4 1/10 (10.00%)  1
Vivid Dreams  1  1/10 (10.00%)  1 1/10 (10.00%)  1
Dry mouth  1  0/10 (0.00%)  0 1/10 (10.00%)  1
Fatigue  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Flushing  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Headache  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Sex inhibition  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Urinary tract infection  1  0/10 (0.00%)  0 1/10 (10.00%)  1
Muscle ache  1  0/10 (0.00%)  0 1/10 (10.00%)  1
Paraesthesia  1  0/10 (0.00%)  0 1/10 (10.00%)  1
drug withdrawal syndrome  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Immune system disorders     
Sore throat  1  0/10 (0.00%)  0 1/10 (10.00%)  1
Psychiatric disorders     
Irritability  1  2/10 (20.00%)  2 3/10 (30.00%)  3
Anxiety  1  1/10 (10.00%)  1 1/10 (10.00%)  1
Dysphoria  1  1/10 (10.00%)  1 1/10 (10.00%)  1
Depression mental  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Panic reaction  1  1/10 (10.00%)  1 1/10 (10.00%)  1
Mental distress  1  2/10 (20.00%)  2 0/10 (0.00%)  0
Reproductive system and breast disorders     
Sexual dysfunction  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Infection Upper Respiratory  1  1/10 (10.00%)  1 1/10 (10.00%)  1
Coughing  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Pneumonia  1  0/10 (0.00%)  0 1/10 (10.00%)  1
Postnasal drip  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders     
Ecchymosis  1  1/10 (10.00%)  1 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
Limitations in funding resulted in a small number of subjects enrolled.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Steve Shoptaw PhD
Organization: University of California, Los Angeles
Phone: 310 794 0619 ext 225
Responsible Party: Steve Shoptaw, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01011829     History of Changes
Other Study ID Numbers: NIDA-18185-PII-3
P50DA018185 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIH / NIDA )
First Submitted: November 9, 2009
First Posted: November 11, 2009
Results First Submitted: November 21, 2012
Results First Posted: March 14, 2013
Last Update Posted: March 14, 2013