AlcoholismPhase 3NCT01169610
Varenicline and Alcohol in Inpatient Addictions Program (IAP)
A Phase 3 study testing Varenicline in people with Alcoholism and Nicotine Dependence, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholism, Nicotine Dependence
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Subjects will be eligible for enrollment if they:
- Are > 18 and < 70 years of age
- Are admitted to the inpatient addiction program (IAP) in the Generose Building at Saint Marys Hospital
- Have been diagnosed with alcohol dependence based on DSM-IV-TR criteria and confirmed by Psychiatric Research Interview for Substance and Mental Disorders (PRISM)
- Smoke at least 10 cigarettes/day for ≥ 6 months
- Are able to participate fully in all aspects of the study
- Have been provided with, understand, and have signed the informed consent; and
- Agree to identify collateral individuals for contact purposes to facilitate follow-up appointments.
Patients will be excluded from participation if they:
- Meet DSM-IV criteria of schizophrenia or other non-affective psychotic disorder
- Have had psychotic symptoms within the past month
- Have an Axis I disorder requiring new pharmacotherapy
- Have a predominant Axis II disorder
- Have used an investigational drug within 30 days of enrollment
- Have started Naltrexone or Acamprosate during this same IAP admission
- Have a history (past 3 months) of drug abuse (excluding caffeine and marijuana)
- Have active suicidality as measured by screening questions from the Columbia-Suicide Severity Rating Scale (C-SSRS), (Posner 2008) outlined below:
- "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
- Have a history of medically serious suicide attempt within 5 years
- Have a history of any major cardiovascular events including arrhythmias, congestive heart failure, unstable angina, acute MI or coronary angioplasty
- Are pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use a reliable form of contraception. Reliable forms of contraception include diaphragm or condom (with spermicidal), injections, intrauterine device [IUD], surgical sterilization and abstinence;
- Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease
- Have another household member or relative participating in the study
- Have a known allergy to varenicline
- Are individuals, in the investigators opinion, unable to comply with study procedures
- Are unable to provide written informed consent in English
- Are on hemodialysis or have a history of kidney disease.
Patients will be excluded from participation in the MR spectroscopy portion of the study if they have:
- Claustrophobia
- A history of major head trauma with loss of consciousness > 5 minutes or skull fracture
- A history of previous neurological event (e.g., epilepsy, stroke, transient ischemic attack)
- Implanted metal objects (e.g., pacemakers; aneurysm clips; metal prostheses, joints, rods, or plates)
- Contraindication to MRI scanning.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A 24-week Open-Label Feasibility Trial of Varenicline for Alcoholic Cigarette Smokers
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.
Read the detailed description
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:
- To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for increasing continuous alcohol abstinence rates at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
- To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for decreasing the number of heavy drinking days (> 5 drinks/day for men and > 4 drink/day for women) at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
- To obtain preliminary data on baseline and baseline to endpoint change in CSF volume corrected concentrations of the dorsal striatal glutamate, glutamate + glutamine, and NAA measures through MR spectroscopy before and after 30 days of varenicline treatment among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
Secondary aims:
- To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for increasing the 7-day point prevalence smoking abstinence rates and prolonged smoking abstinence at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
- To assess the tolerability of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks).
- Conditions
- Alcoholism, Nicotine Dependence
- Being tested
- Varenicline
- Keywords
- Alcohol, Smoking
- Medical subject headings
- Alcoholism, Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
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.
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | Not described Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two years
Secondary outcomes (3)
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.
Measured: 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.
Measured: Two years
Tolerability of Varenicline
Tolerability will be defined by the number of adverse events experienced by patients.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Frye, Mayo Clinic
- Investigators
- Mark Frye, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169610
- Sponsor's protocol ID
- 10-002699
- Status last verified
- Mar 2019
- First submitted
- 22 Jul 2010
- Last updated
- 20 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Open-Label Feasibility Trial of Varenicline for Alcoholic Cigarette Smokers
- ClinicalTrials.gov ID
- NCT01169610
- Acronym / sponsor ID
- 10-002699
- Conditions
- Alcoholism, Nicotine Dependence
- Keywords
- Alcohol, Smoking
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Posted 26 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for increasing continuous alcohol abstinence rates at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
- To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for decreasing the number of heavy drinking days (> 5 drinks/day for men and > 4 drink/day for women) at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
- To obtain preliminary data on baseline and baseline to endpoint change in CSF volume corrected concentrations of the dorsal striatal glutamate, glutamate + glutamine, and NAA measures through MR spectroscopy before and after 30 days of varenicline treatment among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
Secondary aims:
- To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for increasing the 7-day point prevalence smoking abstinence rates and prolonged smoking abstinence at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
- To assess the tolerability of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: Varenicline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: ChantixVarenicline 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. | Drug | Varenicline |
Primary outcome
Continuous Alcohol Abstinence
Time frame: Two years
No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.
Heavy Drinking Days
Time frame: Two years
Number of drinking days > 5 drinks/day for men and > 4 drink/day for women. This will be a self-reported outcome.
3 secondary outcomes
7-day Point Prevalence Smoking Abstinence
Time frame: Two years
Prolonged Smoking Abstinence
Time frame: Two years
Tolerability of Varenicline
Time frame: Two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Frye, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Varenicline in people with Alcoholism and Nicotine Dependence, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Alcohol Abstinence (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.