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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steve Shoptaw, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01011829
First received: November 9, 2009
Last updated: February 11, 2013
Last verified: February 2013
Results First Received: November 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Methamphetamine Dependence
Substance Abuse
Methamphetamine Abuse
Interventions: Drug: Varenicline
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Varenicline 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).
Placebo (Sugar Pill) 8 weeks of daily matching oral placebo in tablet form

Participant Flow:   Overall Study
    Varenicline     Placebo (Sugar Pill)  
STARTED     10     10  
COMPLETED     6     1  
NOT COMPLETED     4     9  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Varenicline 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).
Placebo (Sugar Pill) 8 weeks of daily matching oral placebo in tablet form
Total Total of all reporting groups

Baseline Measures
    Varenicline     Placebo (Sugar Pill)     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  37.1  ± 10.4     35.1  ± 10.5     36.1  ± 10.2  
Gender  
[units: participants]
     
Female     3     4     7  
Male     7     6     13  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo.   [ Time Frame: 8-weeks ]

2.  Secondary:   Retention (Completion)   [ Time Frame: 8-weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations in funding resulted in a small number of subjects enrolled.  


Results Point of Contact:  
Name/Title: Steve Shoptaw PhD
Organization: University of California, Los Angeles
phone: 310 794 0619 ext 225
e-mail: sshoptaw@mednet.ucla.edu


No publications provided


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, DPMC
Study First Received: November 9, 2009
Results First Received: November 21, 2012
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration