Efficacy of Varenicline for Smokeless Tobacco Use in India

NCT01098305 | Completed Phase 2 Results

• 1 other identifier: 811047
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.

Conditions

Tobacco Use Disorder

Keywords

nicotine smokeless tobacco chewing tobacco varenicline

Outcome Measures

Primary Outcomes (1)

• 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.

  At the end of treatment (12 weeks)

Secondary Outcomes (1)

• Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.

  Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

Drug: Varenicline; Behavioral: Counseling

Placebo

PLACEBO COMPARATOR

Behavioral: Counseling

Interventions

Varenicline DRUG

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).

Also known as: Chantix

Varenicline

Counseling BEHAVIORAL

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.

Also known as: Behavioral Counseling

Placebo; Varenicline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males and females
• over age 18
• used smokeless tobacco every day for the past year (confirmed with urinary cotinine)
• residing within 100km of New Dehli for the next 4 months
• interested in quitting use of smokeless tobacco.

You may not qualify if:

• currently enrolled or plan to enroll in another tobacco cessation program in the next 4 months
• plan to use other smoking cessation treatments in the next 4 months
• smoke cigarettes
• have current substance abuse (e.g., opioids, cocaine, marijuana) verified by urine drug screen
• have current (last 6-months) alcohol consumption that exceeds 25 standard drinks/week (if past abuse, must be symptom free for ≥ the past 12 months)
• Current use or discontinuation within last 14 days of:
• smoking cessation medications (bupropion, Varenicline, NRT);
• antipsychotics, atypicals, mood-stabilizers, anti-depressants (tricyclics, SSRIs, MAOIs), anti-panic agents, anti-obsessive agents, anti-anxiety agents, stimulants;
• Anti-coagulants;
• Daily medication for asthma or diabetes (eligible with physician approval);
• are pregnant, planning a pregnancy, or lactating
• have a history or current diagnosis of psychosis, general anxiety disorder,bipolar disorder, or schizophrenia
• have a current diagnosis of depression (if past diagnosis, must be symptom free for ≥ the past 12 months)
• have an allergy to Varenicline
• ever contemplated or attempted suicide

Sponsors & Collaborators

• University of Pennsylvania: lead
• All India Institute of Medical Sciences: collaborator

Study Sites (1)

All India Institute of Medical Research

New Dehli, India

Location

Related Publications (2)

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

• Jhanjee S, Jain R, Jain V, Gupta T, Mittal S, Goelz P, Schnoll RA. Evaluating the Effects of Varenicline on Craving, Withdrawal, and Affect in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline for Smokeless Tobacco Dependence in India. J Psychoactive Drugs. 2015 Sep-Oct;47(4):325-30. doi: 10.1080/02791072.2015.1075092. Epub 2015 Aug 28.

  PMID: 26317176 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline; Counseling; Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Psychotherapy

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Robert Schnoll
• Organization: University of Pennsylvania

schnoll@mail.med.upenn.edu

215-746-7143

Study Officials

• Robert A Schnoll, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: April 2, 2010
• Study Start: April 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2013
• Last Updated: July 30, 2015
• Results First Posted: June 9, 2015

Record last verified: 2015-06

Locations

IN (1)