A Phase 4 interventional study of Long-Term Varenicline and Short-Term Varenicline in Tobacco Use Disorder and Opioid-use Disorder, sponsored by Albert Einstein College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by Albert Einstein College of Medicine · Phase 4, Interventional, and Treatment
This 2 x 2 factorial, randomized, double-blind, placebo-controlled trial will test two interventions: directly observed medication therapy, and long-term therapy with varenicline among smokers with opioid use disorder recruited from community-based, outpatient opioid treatment programs. The analytic strategy will evaluate the milestones in smoking cessation-achieving initial abstinence, preventing lapse and preventing relapse--necessary for long-term cessation, and evaluate theoretically-guided psychological and social factors and pharmacogenetic factors that influence these cessation processes.
Tobacco use and tobacco-related disease are highly prevalent among persons with opioid use disorders (OUD). Unfortunately, traditional evidence-based smoking cessation interventions have yielded low rates of tobacco abstinence in this group. The majority of trials evaluating smoking cessation treatment interventions among persons with OUD have relied on short-term interventions that do not account for the unique challenges faced by these smokers, specifically, establishing initial abstinence, adhering to evidence-based cessation treatments, and maintaining abstinence once active treatments cease. Long-term smoking cessation medication treatment approaches have shown promise in promoting cessation and decreasing relapse among individuals without OUD, however the applicability of extended medication approaches to smokers with OUD may be limited by poor adherence to smoking cessation medications. Though adherence to cessation medication is strongly associated with cessation success, adherence is especially challenging for persons with OUD. Opioid treatment program-based directly observed therapy (DOT) interventions improve clinical outcomes in HIV and TB, and pilot data suggest that DOT varenicline is associated with increased smoking cessation medication adherence and may increase smoking cessation rates. In this 2 x 2 factorial, randomized, double-blind, placebo-controlled trial, the investigators will test two interventions: directly observed medication therapy, and long-term therapy with varenicline. The analytic strategy will evaluate the milestones in smoking cessation-achieving initial abstinence, preventing lapse and preventing relapse--necessary for long-term cessation, and evaluate theoretically-guided psychological and social factors and pharmacogenetic factors that influence these cessation processes. The investigators will recruit smokers with OUD from community-based, outpatient opioid treatment programs and test the following specific aims: (1) to test the efficacy of directly observed varenicline therapy compared to self-administered varenicline therapy on smoking cessation milestones, (2) to test the efficacy of long-term varenicline compared to short-term varenicline on smoking cessation milestones, and (3) to understand the mechanism of smoking cessation by examining the impact of theory-guided psychological and social factors and of pharmacogenetic factors on cessation milestones.
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's enrollment of 243 is above the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Albert Einstein College of Medicine is the lead sponsor of 201 studies on the registry; 21 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 37 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 24 weeks of varenicline at standard doses (0.5 mg/day for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily)
Drug: Long-Term Varenicline
Participants will receive 12 weeks of varenicline at standard doses (0.5 mg/day for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily), followed by matching placebo twice daily through week 24.
Drug: Short-Term Varenicline
Participants receiving directly observed therapy (DOT) will receive varenicline from opioid treatment program nurses at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Behavioral: Directly Observed Therapy
Patients receiving varenicline self administered therapy (SAT) will self-administer all varenicline doses.
Behavioral: Self Administered Therapy
Varenicline tablet x 24 weeks
Also known as: varenicline, chantix
varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg tablet
Also known as: varenicline, chantix, placebo
Varenicline doses are administered by opioid treatment program nurses
Varenicline doses are self-administered
Time-to-initial abstinence
Time-to-initial abstinence, defined as a 24 hour period without smoking, will be assessed as Period of ≥ 24 hour self-reported abstinence during the intervention period, will be assessed. Group mean time-to-initial abstinence will be reported.
Time frame: Up to 24 weeks
Time-to-lapse
Time-to-lapse, defined as the initial occasion of cigarette smoking after abstinence, will be based on the first day during which subjects smoke, even a puff, after a period of initial abstinence. Group mean number of days to time-to-lapse will be reported.
Time frame: Up to 24 weeks
Time to relapse
Time-to-relapse, defined as the return to regular cigarette use, will be based on the time first day of seven consecutive days of self-reported smoking after a period of initial abstinence. Group mean number of days to time-to-relapse will be reported.
Time frame: Up to 24 weeks
Durability of 7-day point prevalence tobacco abstinence
Durability of tobacco abstinence will be assessed using Carbon Monoxide (CO)-verified, 7-day point prevalence abstinence at week 28. Smoking abstinence in accordance with self-reported Timeline Follow Back Method (TLFB), which uses calendar prompts to assess self-reported daily patterns, and verified by expired carbon monoxide (CO) \< 8 ppm, will be reported.
Time frame: week 28
Durability of 7-day point prevalence tobacco abstinence
Durability of tobacco abstinence will be assessed using Carbon Monoxide (CO)-verified, 7-day point prevalence abstinence at week 52. Smoking abstinence in accordance with self-reported Timeline Follow Back Method (TLFB), which uses calendar prompts to assess self-reported daily patterns, and verified by expired carbon monoxide (CO) \< 8 ppm, will be reported.
Time frame: week 52
Number of Cigarettes smoked per day
Group mean of self-reported number of cigarettes smoked per day will be obtained via self-reported TLFB and summarized per group.
Time frame: 24 weeks
Nicotine dependence
Nicotine dependence will be assessed using Fagerström Test of Nicotine Dependence (FTND). FTND is a 6-item instrument designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. Specifically, the FTND evaluates the quantity of cigarette consumption, the compulsion to use, and dependence. Three Yes/No items are scored as either 0 (No) or 1 (Yes). Two multiple-choice items are either scored from 0-3 or 1-3, with higher scores signifying greater nicotine dependence. A final question, "Which cigarette would you hate to give up?" with 'First in the Morning' scored as 1 and 'Any other' scored as 0. The FTND yields an overall score of 0-10. An overall score of 1-2 = "Lowest Dependence", 3-4 = "Low to Moderate Dependence", 5-7 = "Moderate Dependence", and 8+ = "High Dependence"
Time frame: 24 weeks
Quality of life - Physical and Mental Health (SF-36)
Quality of Life will be assessed using the Medical Outcomes Study Short Form 12 (SF-12). The SF-12 is a 12-item general health questionnaire, derived from the Medical Outcomes Study 36 item Short Form Survey (SF-36), is designed to have similar performance as the SF-36, while taking less time to complete. The SF-12 asks a series of questions measuring eight health domains assessing both physical (PCS-12) and mental health (MCS-12). Two summary scores are generated: a mental component score (MCS-12), and a physical component score (PCS-12). Scores for both range from 0-100 with higher scores indicating better physical and mental health functioning, respectively. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition, while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'. Group mean scores will be reported.
Time frame: 24 weeks
Plan to share: Yes — Our final dataset will include: survey and laboratory data, including demographic, medical, tobacco, and other substance use-related information about all clinical trial subjects. The final dataset will be stripped of all personal identifiers.
Supporting information: Study protocol, Analytic code
Time frame: After data collection and cleaning is complete.
Access criteria: We will share data with qualified investigators whose research protocols have been approved by their institutions' Institutional Review Boards. Data will be made available to potential users under a NIDA-approved data-sharing agreement that ensures that: (1) data is used only for research purposes and does not identify individual participants; (2) data is handled in a secure and confidential way; and (3) data is destroyed or returned after analyses are completed.
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Nov 2023, 60 months.
Of 38 non-industry phase 4 interventional studies under Tobacco Use Disorder, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 55. This study's 60 months is above that.
Counting every sponsor, half of 38 studies reached it within 41 months; a quarter within 30 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Varenicline
Albert Einstein College of Medicine →