Efficacy of Varenicline for Smokeless Tobacco Use in India

This study has been completed.
Sponsor:
Collaborator:
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01098305
First received: March 23, 2010
Last updated: July 9, 2015
Last verified: June 2015
Results First Received: May 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Interventions: Drug: Varenicline
Behavioral: Counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Varenicline

Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).

Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.

Placebo Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.

Participant Flow:   Overall Study
    Varenicline     Placebo  
STARTED     119     118  
COMPLETED     88     85  
NOT COMPLETED     31     33  
Lost to Follow-up                 31                 33  



  Baseline Characteristics
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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: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).

Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.

Placebo Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
Total Total of all reporting groups

Baseline Measures
    Varenicline     Placebo     Total  
Number of Participants  
[units: participants]
  119     118     237  
Age  
[units: years]
Mean (Standard Deviation)
  33.8  (8.4)     34.7  (9.9)     34.2  (9.2)  
Gender  
[units: participants]
     
Female     3     4     7  
Male     116     114     230  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.   [ Time Frame: At the end of treatment (12 weeks) ]

2.  Secondary:   Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.   [ Time Frame: Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Sample size and reduced power; lack of long-term assessments; a priori inclusion of covariates in prediction models; adherence to medication was low.


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


Results Point of Contact:  
Name/Title: Dr. Robert Schnoll
Organization: University of Pennsylvania
phone: 215-746-7143
e-mail: schnoll@mail.med.upenn.edu


No publications provided


Responsible Party: Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01098305     History of Changes
Other Study ID Numbers: 811047
Study First Received: March 23, 2010
Results First Received: May 26, 2015
Last Updated: July 9, 2015
Health Authority: India: Institutional Review Board
India: Indian Council of Medical Research