NCT03557294: VOTC

Varenicline OTC Trial on Efficacy and Safety

Completed Phase 4 Results posted Last updated 19 September 2024

What this trial tests

Phase 4 trial testing 1.0mg Varenicline b.i.d. in Tobacco Dependence in 313 participants. Completed in 16 April 2022.

Timeline

7 May 2018

Primary endpoint
16 April 2022

16 April 2022

Quick facts

Lead sponsor	Arizona State University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	313
Start date	7 May 2018
Primary completion	16 April 2022
Estimated completion	16 April 2022
Sites	2 locations across United States

Drugs / interventions tested

• 1.0mg Varenicline b.i.d. (1-0mg-varenicline-b-i-d) — full drug profile →
• 0.5mg Varenicline b.i.d. (0-5mg-varenicline-b-i-d) — full drug profile →
• 0.0mg placebo Varenicline b.i.d. — full drug profile →

Conditions studied

• Tobacco Dependence — all drugs for Tobacco Dependence →
• Withdrawal Symptoms — all drugs for Withdrawal Symptoms →
• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Arizona State University

Who can join

21 and older, any sex, with Tobacco Dependence or Withdrawal Symptoms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Participants Who Have Continuous Abstinence as Verified by Breath Carbon Monoxide or Urine Cotinine Primary · Week 12

Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - Continuous abstinence

Group	Value	95% CI
1.0mg Varenicline b.i.d.	17
0.5mg Varenicline b.i.d.	9
0.0mg Placebo Varenicline b.i.d.	9

Breath Carbon Monoxide or Urine Cotinine Verified Abstinence From Smoking Cigarettes - Point Prevalence Abstinence Secondary · Week 12 visit

Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - point prevalence abstinence

Group	Value	95% CI
1.0mg Varenicline b.i.d.	25
0.5mg Varenicline b.i.d.	12
0.0mg Placebo Varenicline b.i.d.	9

Breath Carbon Monoxide Verified Abstinence From Smoking Cigarettes Secondary · Week 26

Participants who self report not smoking will be asked to have smoking status verified by breath carbon monoxide

Group	Value	95% CI
1.0mg Varenicline b.i.d.	16
0.5mg Varenicline b.i.d.	11
0.0mg Placebo Varenicline b.i.d.	11

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

1.0mg Varenicline b.i.d.

Serious: 0/104 (0%)

Deaths: 0/104

0.5mg Varenicline b.i.d.

Serious: 0/104 (0%)

Deaths: 0/104

0.0mg Placebo Varenicline b.i.d.

Serious: 2/105 (2%)

Deaths: 0/105

Serious adverse events (2 terms)

Reaction	System	1.0mg Varenicline b.i.d.	0.5mg Varenicline b.i.d.	0.0mg Placebo Varenicline …
Asthma Attack	Respiratory, thoracic and mediastinal disorders	—	—	—
Stab Wound	Injury, poisoning and procedural complications	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	1.0mg Varenicline b.i.d.	0.5mg Varenicline b.i.d.	0.0mg Placebo Varenicline …
Nausea	Gastrointestinal disorders	—	—	—
Vivid Dreams	General disorders	—	—	—
Insomnia	General disorders	—	—	—
Irritability	Psychiatric disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—

Most-reported serious reactions: Asthma Attack, Stab Wound.

Data from ClinicalTrials.gov NCT03557294 adverse events section.

Sponsor's own description

The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.

Publications & conference data

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

1. 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
2. Nicotine receptor partial agonists for smoking cessation
   Livingstone-Banks J, Fanshawe T, Thomas K, Theodoulou A, et al · · 2023