Varenicline for Adolescent Smoking Cessation

NCT01509547 | Completed Phase 3 Results DMC

• 1 other identifier: Pro00014398
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment

  Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit

  7 days at end of treatment

• Number of Participants Experiencing Treatment-emergent Adverse Events

  Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment.

  26 weeks (12 weeks of treatment plus full post-treatment follow-up)

Secondary Outcomes (3)

• Percentage of Visits With Abstinence During Treatment

  12 weeks (all of active treatment)

• Percentage of Post-treatment Visits With Abstinence

  One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits

• Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment

  12 weeks of active treatment

Study Arms (2)

varenicline

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Varenicline DRUG

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.

Also known as: Chantix

varenicline

placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 14-21
• Daily smoker for ≥6 months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

  PMID: 34611902 DERIVED

• Gray KM, Baker NL, McClure EA, Tomko RL, Squeglia LM, Saladin ME, Carpenter MJ. Efficacy and Safety of Varenicline for Adolescent Smoking Cessation: A Randomized Clinical Trial. JAMA Pediatr. 2019 Dec 1;173(12):1146-1153. doi: 10.1001/jamapediatrics.2019.3553.

  PMID: 31609433 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline

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

Results Point of Contact

• Title: Kevin M. Gray, M.D.
• Organization: Medical University of South Carolina

graykm@musc.edu

843-792-6330

Study Officials

• Kevin M Gray, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: December 14, 2011
• First Posted: January 13, 2012
• Study Start: August 1, 2012
• Primary Completion: January 26, 2018
• Study Completion: January 26, 2018
• Last Updated: July 1, 2020
• Results First Posted: March 11, 2019

Record last verified: 2020-06

Locations

US (1)