NCT00828113

Long-term Varenicline Treatment for Smoking Cessation

Completed Phase 4 Results posted Last updated 22 October 2015

What this trial tests

Phase 4 trial testing varenicline in Smoking in 101 participants. Completed in 1 February 2011.

Timeline

1 January 2009

Primary endpoint
1 September 2010

1 February 2011

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	101
Start date	1 January 2009
Primary completion	1 September 2010
Estimated completion	1 February 2011
Sites	2 locations across United States

Drugs / interventions tested

• varenicline (varenicline) — full drug profile →
• varenicline (varenicline) — full drug profile →
• Individual smoking cessation counseling

Conditions studied

• Smoking — all drugs for Smoking →

Sponsor

University of Wisconsin, Madison

Who can join

Adults 18 to 75, any sex, with Smoking. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52
  Time frame: 7-day point prevalence
  Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of \< 10 parts per million as assessed at Week 52

Sponsor's own description

This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nicotine receptor partial agonists for smoking cessation.
   Cahill K, Lindson-Hawley N, Thomas KH, Fanshawe TR, et al · · 2016 · cited 228× · PMID 27158893 · DOI 10.1002/14651858.cd006103.pub7
2. Nicotine receptor partial agonists for smoking cessation.
   Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, et al · · 2023 · cited 62× · PMID 37142273 · DOI 10.1002/14651858.cd006103.pub8
3. Nicotine receptor partial agonists for smoking cessation
   Livingstone-Banks J, Fanshawe T, Thomas K, Theodoulou A, et al · · 2023