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Tailoring Varenicline to Individual Needs (TVIN Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Al-Rehan Abdul Aziz Dhanji, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01206010
First received: September 14, 2010
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

Varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors. It is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions (primarily nausea) in sensitive clients. The downside of this cautious approach is that a substantial proportion of clients may be under-dosed. A blanket dose increase would inevitably increase the incidence of side effects, but it is likely that tailoring varenicline dosing to clients' needs would be safe and may further increase varenicline's efficacy.

This study will recruit 200 smokers who report little change to their enjoyment of cigarettes and no nausea, during the first week of varenicline use. These smokers will be randomised to receive the standard dose plus placebo or plus individualised varenicline dose up to 5mg, titrated over the next week prior to their target quit day. Urges to smoke, and other withdrawal symptoms, experienced during the study period will be compared between groups to see if the tailored therapy may be useful.


Condition Intervention Phase
Tobacco Dependence
Smoking Cessation
 Drug: Varenicline
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Tailored Dose of Varenicline on Post-quitting Urges to Smoke

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Rating of urges to smoke 1-week after the target quit [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Rating of urges to smoke will be assessed using the Mood & Physical Symptoms Scale


Secondary Outcome Measures:
  • Identification of the number of people with no effect of varenicline (as measured on a self reported questionnaire) prior to the target quit date [ Time Frame: 2 weeks pre quitting ] [ Designated as safety issue: No ]
  • The change of withdrawal symptoms from target quit day over the first 4-weeks of abstinence assessed by the Mood and Physical Symptoms Scale [ Time Frame: 4 weeks post quitting ] [ Designated as safety issue: No ]
  • Validated abstinence rates at 1-12 weeks post target quit date [ Time Frame: 1-12 weeks post target quit date ] [ Designated as safety issue: No ]
  • Profile of all adverse effects (as measured by a self reported questionnaire) reported up to 12-weeks post quitting [ Time Frame: Up to 12 weeks post quitting ] [ Designated as safety issue: Yes ]
  • Client ratings (measured using a self-reporting questionnaire) of tailored treatment regimen [ Time Frame: Up to 12 weeks post quit ] [ Designated as safety issue: No ]
  • Rating of urges to smoke 24 hours post target quit date [ Time Frame: 24 hours post target quit date ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: July 2011
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline + Active Tailored Dose Drug: Varenicline
Participants will increase varenicline dose by 0.5 mg twice daily every three days to a maximum of 2.5 mg twice daily. This increased dose will be continued for 3-weeks before being reduced to the standard dose of 1.0 mg twice daily.
Other Names:
  • Champix
  • Chantix
Drug: Varenicline
All participants will receive the standard dose of Varenicline (14 weeks): 0.5 mg once daily for days 1-3, 0.5 mg twice daily for days 4-7, and then a continuation dose of 1.0 mg twice daily. In addition to this participants will use an tailored varenicline/placebo dose up to maximum of 2.5 mg twice daily for 3 weeks.
Other Names:
  • Champix
  • Chantix
Placebo Comparator: Varenicline + Placebo Tailored Dose Drug: Placebo
Participants will increase placebo dose by 0.5 mg twice daily every three days to a maximum of 2.5 mg twice daily. This increased dose will be continued for 3-weeks before being reduced to the standard varenicline dose of 1.0 mg twice daily.
Other Names:
  • Champix
  • Chantix
Drug: Varenicline
All participants will receive the standard dose of Varenicline (14 weeks): 0.5 mg once daily for days 1-3, 0.5 mg twice daily for days 4-7, and then a continuation dose of 1.0 mg twice daily. In addition to this participants will use an tailored varenicline/placebo dose up to maximum of 2.5 mg twice daily for 3 weeks.
Other Names:
  • Champix
  • Chantix

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smoker seeking treatment
  • Aged 18 and over
  • Consenting to take part
  • Report little or no change in enjoyment of cigarettes and/or nausea

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Have severe kidney disease
  • Have severe heart problems
  • Have a current psychiatric illness
  • Are unable to fill in questionnaires in English
  • Have an allergy to varenicline
  • Are currently involved in another clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206010

Locations
United Kingdom
Tobacco Dependence Research and Treatment Unit
London, United Kingdom, E1 2JH
Sponsors and Collaborators
Queen Mary University of London
Investigators
Principal Investigator: Al-Rehan Abdul Aziz Dhanji, MB.BS., BSc.,MRCS. Queen Mary University of London
  More Information

No publications provided

Responsible Party: Dr. Al-Rehan Abdul Aziz Dhanji, Clinical Fellow in Cardiothoracic Surgery, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01206010     History of Changes
Other Study ID Numbers: qmul010610, 2010-022335-11
Study First Received: September 14, 2010
Last Updated: April 24, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency (approved Jan 2011, 22310/0006/001-0001)
United Kingdom: Research Ethics Committee

Keywords provided by Queen Mary University of London:
Tobacco Dependence
Smoking cessation
Varenicline
Tailored dosing

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013