Smoking Cessation Clinical Trial
Official title:
A Comparison of the Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy Versus Varenicline Alone for Smoking Cessation: a Pilot Study
Verified date | January 2024 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Varenicline is considered to be a first-line tobacco cessation treatment. Previous studies have evaluated the impact of the combination of varenicline and nicotine patches (versus varenicline alone) on smoking cessation, though findings have been equivocal. No studies to date have evaluated the combination of varenicline and oral nicotine replacement therapy (NRT; i.e., nicotine lozenges or gum). Nicotine lozenges and gum can provide acute relief during cravings and high risk situations, which offers individuals the flexibility to deliver nicotine when they need it most (in contrast with the continuous and passive delivery of nicotine offered via the patch). Prospective clinical trials are needed in real-world settings to determine whether the combination of varenicline and oral nicotine replacement therapy (i.e., lozenges, gum) is superior to varenicline alone for smoking cessation. The proposed pilot randomized trial would enroll 100 participants over 1 year (≈8 participants per month) utilizing a 2x2 factorial design. Twelve weeks of a pharmacological intervention [varenicline + oral NRT (VAR+N) vs. varenicline alone (VAR)] will be crossed with automated medication reminders (reminder messages vs. no reminder messages). All participants will receive an adapted version of the standard counseling offered through the Tobacco Treatment Research Program (TTRP). The primary outcomes will be biochemically-verified smoking cessation at 12 and 26 weeks following a scheduled quit attempt (1 week after enrollment). Smartphone-based ecological momentary assessment (EMA) will be employed to measure withdrawal symptoms, medication adherence, side effects, and adverse events using the Insight™ platform developed by the Stephenson Cancer Center (SCC) mHealth Shared Resource. This pilot study will provide information regarding the feasibility, acceptability, and preliminary efficacy of combination varenicline and oral NRT for smoking cessation, which will support an NIH funding application for a larger, adequately powered study.
Status | Terminated |
Enrollment | 34 |
Est. completion date | February 7, 2022 |
Est. primary completion date | February 7, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - = 18 years of age - = 6th grade English literacy - agree to use personal or study-provided smartphone/applications - agree to complete phone-based or in-person surveys throughout 26 week study - expired CO > 6 ppm at baseline visit (suggesting current smoker) - currently smoke = 5 cigarettes per day - willing to make quit attempt 7 days after baseline visit Exclusion Criteria: - < 18 years of age - history of seizures or allergic reaction to varenicline - report current suicidality - taking anti-depressants or anti-psychotic medications - pregnant or planning to become pregnant - currently breastfeeding |
Country | Name | City | State |
---|---|---|---|
United States | TSET Health Promotion Research Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma | Pfizer |
United States,
Sifat M, Hebert ET, Ahluwalia JS, Businelle MS, Waring JJC, Frank-Pearce SG, Bryer C, Benson L, Madison S, Planas LG, Baranskaya I, Kendzor DE. Varenicline Combined With Oral Nicotine Replacement Therapy and Smartphone-Based Medication Reminders for Smoki — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biochemically-Verified Smoking Cessation | Self-reported abstinence over the prior 7-days with a carbon monoxide value <7 ppm (in exhaled breath) at 12 weeks post-quit date | 12 weeks post-quit date | |
Primary | Biochemically-Verified Smoking Cessation | Self-reported abstinence over the prior 7-days in conjunction with a carbon monoxide value <7 ppm (in exhaled breath) at 26 weeks post-quit date | 26 weeks post-quit date | |
Secondary | Varenicline Adherence | Total number of days of complete varenicline adherence from 1-week pre-quit through 12 weeks post-quit (91 days possible). Complete varenicline adherence was indicated when participants reported taking varenicline daily as prescribed. | 1 week pre-quit though 12 weeks following a scheduled quit date (13 weeks) | |
Secondary | Oral NRT Adherence | Average daily pieces of gum/lozenges used over the first 12 weeks following a scheduled quit date. | 12 weeks post-quit date |
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