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Tobacco Use DisorderPhase 2NCT01098305

Efficacy of Varenicline for Smokeless Tobacco Use in India

A Phase 2 study testing Varenicline and Counseling in people with Tobacco Use Disorder, run by University of Pennsylvania at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco Use Disorder
What is being tested?
Varenicline and Counseling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
237 participants
Where
1 siteIndia
Study dates
Apr 2011to Oct 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 22Show fewer
  • 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
  • have serious/unstable disease within the past 6 months (e.g., cancer [but melanoma], heart disease, HIV/AIDS)
  • have a history of epilepsy or seizure disorder
  • have a history or diagnosis within the last 6 months of abnormal rhythms and/or tachycardia (>100 beats/minute)
  • have a history or current diagnosis of COPD; cardiovascular disease (stroke, angina); heart attack in the last 6 months; and/or uncontrolled hypertension (SBP>150 or DBP>90)16)
  • have a history of kidney or liver failure
  • have any medical condition or medication that could compromise safety as determined by a study physician
  • cannot provide informed consent or complete the study tasks as determined by the Principal Investigator or study physician.

Trial locations and contacts

1 site in 1 country.

India1 site

  • All India Institute of Medical Research

    New Dehli

Other trials in India

About this study

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

Read the detailed description

The prevalence of smokeless tobacco use in the United States is low vs. cigarette smoking, yet rates have remained constant over the past few years. In contrast, the rate of smokeless tobacco use in India is 20%. Smokeless tobacco is a carcinogenic and responsible for ~10,000 deaths/year from oral cancer in India. Unfortunately, there have been remarkably few intervention trials in India for smokeless tobacco users. To date, no trial has evaluated the new FDA approved medication, varenicline, for smokeless tobacco use. We will conduct a randomized placebo-controlled trial of varenicline for smokeless tobacco dependence at the National Drug Dependence Treatment Center (NDDTC) at the All India Institute of Medicine (AIIMS) in New Delhi with 237 smokeless tobacco users. The primary aims of this trial are to: 1) enhance research capacity at the NDDTC (i.e., train AIIMS staff to implement the behavioral counseling protocol with pharmacotherapy, data collection and management procedures); 2) assess the efficacy of varenicline for increasing biochemically confirmed 7-day point prevalence smokeless tobacco quit rates at the end-of treatment; and 3) assess longitudinal patterns of relapse and recovery following treatment with varenicline. The results of this trial may guide future investments to evaluate the efficacy of varenicline for smokeless tobacco dependence in the US, which is critical since smokeless tobacco use in the US may increase in the coming years and no approved pharmacotherapy for this drug dependence exists in the US or around the globe.

Being tested
Varenicline, Counseling
Keywords
nicotine smokeless tobacco chewing tobacco varenicline
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VareniclineDrug

    Also called Chantix

    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).

  • CounselingBehavioural

    Also called Behavioral 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.

Study groups in NCT01098305
Study groupRoleWhat they receive
VareniclineActive comparatorNot described
Receives: Drug: Varenicline; Behavioral: Counseling
PlaceboPlacebo comparatorNot described
Receives: Behavioral: Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.

    Measured: At the end of treatment (12 weeks)

Secondary outcomes (1)

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

    Side Effects

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2010 (estimated)
  2. Study startApr 2011
  3. Primary completionOct 2012
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
237 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01098305
Sponsor's protocol ID
811047
Status last verified
Jun 2015
First submitted
23 Mar 2010
Last updated
30 Jul 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 37142273

  • 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.

    PubMed 26317176

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Varenicline and Counseling in people with Tobacco Use Disorder, run by University of Pennsylvania at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01098305, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.

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