Effects of Chantix on Relapse Prevention for Smoking Cessation

NCT00948649 | Completed Phase 4

• 1 other identifier: 805394
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.

Conditions

Nicotine Dependence

Keywords

Varenicline, Working memory

Outcome Measures

Primary Outcomes (1)

• Days of abstinence following the programmed lapse

  7 days

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

Participants will complete a 21-day study phase that will include a 10-day drug run-up and monitoring phase (days 1-10), a 3-day abstinence phase (days 11-13), and a programmed lapse (day 14) followed by a 7-day observation phase in which participants are asked to remain abstinent and will receive modest monetary reinforcement for doing so (days 15-21).

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Participants will complete a 21-day study phase that will include a 10-day drug run-up and monitoring phase (days 1-10), a 3-day abstinence phase (days 11-13), and a programmed lapse (day 14) followed by a 7-day observation phase in which participants are asked to remain abstinent and will receive modest monetary reinforcement for doing so (days 15-21).

Drug: Placebo

Interventions

Placebo DRUG

Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.

Placebo

Varenicline DRUG

Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - End of Treatment 1.0mg twice daily

Also known as: Chantix

Varenicline

Eligibility Criteria

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

You may qualify if:

• Eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline CO reading ≥ 10 ppm and who plan to live in the area for the next 6-months.

You may not qualify if:

• Smoking Behavior
• Use of chewing tobacco or snuff
• Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
• Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
• Provide a baseline CO reading \< 10 ppm
• History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants)
• Current alcohol consumption that exceeds \>25 standard drinks/week
• \. Current use or recent discontinuation (within last 14-days) of the following medications:
• Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT)
• Any form of anti-psychotic medications that includes:
• antipsychotics,
• atypical antipsychotics,
• mood-stabilizers,
• anti-depressants (tricyclics, SSRI's, MAOI's),
• anti-panic agents,

Sponsors & Collaborators

• University of Pennsylvania: lead
• AstraZeneca: collaborator

Study Sites (1)

Tobacco Use Research Center, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• Patterson F, Jepson C, Strasser AA, Loughead J, Perkins KA, Gur RC, Frey JM, Siegel S, Lerman C. Varenicline improves mood and cognition during smoking abstinence. Biol Psychiatry. 2009 Jan 15;65(2):144-9. doi: 10.1016/j.biopsych.2008.08.028. Epub 2008 Oct 8.

  PMID: 18842256 RESULT

• Rudnick ND, Strasser AA, Phillips JM, Jepson C, Patterson F, Frey JM, Turetsky BI, Lerman C, Siegel SJ. Mouse model predicts effects of smoking and varenicline on event-related potentials in humans. Nicotine Tob Res. 2010 Jun;12(6):589-97. doi: 10.1093/ntr/ntq049. Epub 2010 Apr 15.

  PMID: 20395358 RESULT

• Patterson F, Jepson C, Loughead J, Perkins K, Strasser AA, Siegel S, Frey J, Gur R, Lerman C. Working memory deficits predict short-term smoking resumption following brief abstinence. Drug Alcohol Depend. 2010 Jan 1;106(1):61-4. doi: 10.1016/j.drugalcdep.2009.07.020. Epub 2009 Sep 5.

  PMID: 19733449 RESULT

• 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

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

Study Officials

• Caryn Lerman, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: September 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 17, 2010

Record last verified: 2009-07

Locations

US (1)