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Varenicline for Adolescent Smoking Cessation

This study is currently recruiting participants.
Verified March 2013 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Kevin Gray, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01509547
First received: December 14, 2011
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo. All participants will concurrently participate in a contingency management (CM) intervention, specifically designed to reinforce participant retention.


Condition Intervention Phase
Nicotine Dependence
 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, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • self-report of cigarettes per day [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • change in urine cotinine measurement [ Time Frame: baseline, end of treatment (12 weeks) and final post-treatment follow-up (26 weeks) ] [ Designated as safety issue: No ]
  • Biological confirmation of smoking with carbon monoxide breathalyzer [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • frequency of treatment-emergent adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 166
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: varenicline
Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.
 Drug: Varenicline
participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Other Name: Chantix
Placebo Comparator: placebo
Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.
 Drug: placebo
participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 14-21
  • Daily smoker for ≥6 months, smoking ≥5 cigarettes per day on average in the past month
  • Desire to quit smoking, with at least one prior failed quit attempt and willingness to participate in a treatment study
  • If under age 18, parent(s) or guardian(s) able to participate in informed consent and initial assessment (unless the participant provides evidence of emancipated status)
  • If female, agreement to use birth control (any form of hormonal contraception such as Depo-Provera, daily oral contraception, transdermal patch, or Nuva-ring; intrauterine device; sterilization; or double barrier contraception, which is a combination of any two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy

Exclusion Criteria:

  • Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia)
  • Lifetime history of suicidality, homicidality, or clinically significant hostility/aggression
  • Current substance dependence, other than nicotine
  • Current unstable major medical disorder
  • Current pregnancy or breastfeeding
  • Current use of medications with smoking cessation efficacy
  • Known hypersensitivity to varenicline
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509547

Contacts
Contact: Christine Horne 843-792-5807 hornechr@musc.edu
Contact: Ashley McCullough 843-792-5842 mccullos@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Horne     843-792-5807        
Principal Investigator: Kevin M Gray, MD            
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Kevin M Gray, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Kevin Gray, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01509547     History of Changes
Other Study ID Numbers: Pro00014398
Study First Received: December 14, 2011
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tobacco Use Disorder
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 21, 2013