NCT01314001

Pharmacogenetics of Nicotine Addiction Treatment (PNAT)

Completed Phase 3 Results posted Last updated 3 February 2016

What this trial tests

Phase 3 trial testing Varenicline in Nicotine Addiction in 1,246 participants. Completed in 1 September 2014.

Timeline

1 December 2010

Primary endpoint
1 December 2013

1 September 2014

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	1,246
Start date	1 December 2010
Primary completion	1 December 2013
Estimated completion	1 September 2014
Sites	4 locations across United States, Canada

Drugs / interventions tested

• Varenicline (varenicline) — full drug profile →
• Placebo
• Transdermal Nicotine

Conditions studied

• Nicotine Addiction — all drugs for Nicotine Addiction →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 65, any sex, with Nicotine Addiction. Patients with the condition only — healthy volunteers not accepted.

What's being measured

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

• 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT)
  Time frame: Week 11
  The percentage of ITT subjects who were verified as abstinent. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who

Sponsor's own description

The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.

Publications & conference data

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

1. Use of the nicotine metabolite ratio as a genetically informed biomarker of response to nicotine patch or varenicline for smoking cessation: a randomised, double-blind placebo-controlled trial.
   Lerman C, Schnoll RA, Hawk LW, Cinciripini P, et al · · 2015 · cited 247× · PMID 25588294 · DOI 10.1016/s2213-2600(14)70294-2
2. 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
3. Smoking cessation for improving mental health.
   Taylor GM, Lindson N, Farley A, Leinberger-Jabari A, et al · · 2021 · cited 160× · PMID 33687070 · DOI 10.1002/14651858.cd013522.pub2
4. Known and novel sources of variability in the nicotine metabolite ratio in a large sample of treatment-seeking smokers.
   Chenoweth MJ, Novalen M, Hawk LW, Schnoll RA, et al · · 2014 · cited 94× · PMID 25012994 · DOI 10.1158/1055-9965.epi-14-0427
5. Nicotine metabolite ratio (3-hydroxycotinine/cotinine) in plasma and urine by different analytical methods and laboratories: implications for clinical implementation.
   Tanner JA, Novalen M, Jatlow P, Huestis MA, et al · · 2015 · cited 70× · PMID 26014804 · DOI 10.1158/1055-9965.epi-14-1381
6. The relationship between the nicotine metabolite ratio and three self-report measures of nicotine dependence across sex and race.
   Schnoll RA, George TP, Hawk L, Cinciripini P, et al · · 2014 · cited 56× · PMID 24402139 · DOI 10.1007/s00213-013-3421-1
7. Evaluating the temporal relationships between withdrawal symptoms and smoking relapse.
   Robinson JD, Li L, Chen M, Lerman C, et al · · 2019 · cited 54× · PMID 30614717 · DOI 10.1037/adb0000434
8. Differences in the rate of nicotine metabolism among smokers with and without HIV.
   Ashare RL, Thompson M, Leone F, Metzger D, et al · · 2019 · cited 46× · PMID 30946162 · DOI 10.1097/qad.0000000000002127