A Phase 3 interventional study of Varenicline in Alcoholism and Nicotine Dependence, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-03-20.
Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment
The overall hypothesis of this line of research is that varenicline will decrease alcohol consumption and tobacco use and will increase alcohol and tobacco abstinence rates. In order to explore this hypothesis, the investigators will conduct a two-phase study: 1) an open label pilot study investigating the effect of varenicline on reduction of and abstinence from alcohol and tobacco; and 2) an optional MR spectroscopy to investigate whether glutamate and other brain metabolites correlate to measures of alcohol craving severity and/or subsequent varenicline treatment response.
The goal of this proposal is to explore the potential efficacy of varenicline for reducing alcohol consumption among alcohol-dependent cigarette smokers. The hypothesis for the current study is that 24 weeks of varenicline will increase alcohol abstinence rates among smokers and decrease alcohol consumption among patients receiving inpatient addiction treatment for alcoholism. The investigators will also explore whether varenicline has a beneficial effect on tobacco abstinence rates in this population of tobacco users.
The investigators will conduct an open-label pilot study to determine clinical efficacy and employ neuroimaging techniques to evaluate how glutamate and other brain metabolites correlate to measures of alcohol craving severity and/or subsequent varenicline treatment response. The investigators will enroll 20 subjects receiving treatment in the Mayo Clinic Inpatient Addictions Program (IAP) and compare outcomes with patients participating in a similar 6-month open-label study of acamprosate.
The Primary aims of this study are:
Secondary aims:
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This study's enrollment of 1 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
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Subjects will be eligible for enrollment if they:
Patients will be excluded from participation if they:
Have active suicidality as measured by screening questions from the Columbia-Suicide Severity Rating Scale (C-SSRS), (Posner 2008) outlined below:
a. "Yes" response to questions 1, 2, or 3 with significant intensity level endorsed as: i. Frequency: score of 4 or 5 ii. Duration: score of 3, 4 or 5 iii. Controllability: score of 0, 4, or 5 iv. Deterrents: score of 0, 4 or 5 v. Reasons for Ideation: score of 1, 2, 3, 4 or 5 b. "Yes" response to question 4 c. "Yes" response to question 5
Patients will be excluded from participation in the MR spectroscopy portion of the study if they have:
Drug: Varenicline
Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
Also known as: Chantix
Continuous Alcohol Abstinence
No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.
Time frame: Two years
Heavy Drinking Days
Number of drinking days \> 5 drinks/day for men and \> 4 drink/day for women. This will be a self-reported outcome.
Time frame: Two years
7-day Point Prevalence Smoking Abstinence
Negative response to the question, "Have you used any type of tobacco, even a puff, in the past 7 days." This will be a self-reported outcome biochemically-confirmed with exhaled-air carbon monoxide (CO) \< 8 parts per million (ppm) during the medication phase.
Time frame: Two years
Prolonged Smoking Abstinence
Self-reported all tobacco abstinence since two weeks after target quit date (TQD) which will be during their 28-day stay in the IAP on day 8 of varenicline therapy. Negative response to the question, "Have you used any type of tobacco, even a puff, for 7 consecutive days or at least once each week on two consecutive weeks since xx/xx/xxxx?" Note: xx/xx/xxxx corresponds to the date two weeks after the target quit date (TQD). Biochemically-confirmed abstinence at the visit for which prolonged abstinence is being obtained.
Time frame: Two years
Tolerability of Varenicline
Tolerability will be defined by the number of adverse events experienced by patients.
Time frame: Two years
Recruitment period 1/2011 - 9/2012
| Milestone | Open Label |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.
No measurements were reported for this outcome.
Number of drinking days \> 5 drinks/day for men and \> 4 drink/day for women. This will be a self-reported outcome.
No measurements were reported for this outcome.
Negative response to the question, "Have you used any type of tobacco, even a puff, in the past 7 days." This will be a self-reported outcome biochemically-confirmed with exhaled-air carbon monoxide (CO) \< 8 parts per million (ppm) during the medication phase.
No measurements were reported for this outcome.
Self-reported all tobacco abstinence since two weeks after target quit date (TQD) which will be during their 28-day stay in the IAP on day 8 of varenicline therapy. Negative response to the question, "Have you used any type of tobacco, even a puff, for 7 consecutive days or at least once each week on two consecutive weeks since xx/xx/xxxx?" Note: xx/xx/xxxx corresponds to the date two weeks after the target quit date (TQD). Biochemically-confirmed abstinence at the visit for which prolonged abstinence is being obtained.
No measurements were reported for this outcome.
Tolerability will be defined by the number of adverse events experienced by patients.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Label | — | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Open Label |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Age, Continuous(years) | Open Label |
|---|
| Sex: Female, Male(Participants) | Open Label |
|---|---|
| Female | 0 |
| Male | 1 |
| Region of Enrollment(participants) | Open Label |
|---|---|
| United States | 1 |
This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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