AlcoholismPhase 2ChANCT00705523
Varenicline (Chantix™) for the Treatment of Alcohol Dependence
A Phase 2 study testing varenicline in people with Alcoholism, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the treatment of alcohol dependence. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2011
- Phase
- Phase 2
- 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
Who may be able to join
- 1. Males and females, 18-70 years old.
- 2. Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the SCID-IV (First, 1996).
- 3. Meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell, 1995)
- drank within 30 days of intake day,
- reports a minimum of 48 standard alcoholic drinks (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and
- has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in this same pre-treatment period.
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- 4. Three consecutive days of abstinence from alcohol, determined by self-reports and confirmed by a negative breathalyzer tests immediately before the day of randomization, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan, 1989) score below eight on the day of randomization.
- 5. Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
- Speaks, understands, and prints in English.
Who cannot join
- Has evidence of dependence on a substance other than alcohol (except nicotine or marijuana); or tests positive on the urine drug screen and on a single allowed retest, during the screening week, with the exception of a THC positive urine, and/or a).positive result for benzodiazepines prescribed by a doctor for medically indicated detox (prescription required).
- Has hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 4.5 times normal after the required 3 days of abstinence, or elevated bilirubin (>1.3) (one retest allowed at the discretion of the Medical Director).
- Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness. For example, bipolar affective disorder, schizophrenia or any other psychotic disorder, or organic mental disorder; has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
- Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication (with the exception of detoxification medications or benadryl used sparingly for sleep).
- Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months, is nursing, or is not using an effective contraceptive method if the subject is of child-bearing potential.
- Has participated in any investigational drug trial within 30 days prior to the study. Subjects mandated to treatment based upon a legal decision or as a condition of employment. This will be assessed by the subject's self-report.
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- Known hypersensitivity to varenicline.
- Subjects with known AIDS or other serious illnesses that may require hospitalization during the study.
- Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator. (ECG 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests [LFTs] <5 x ULN are acceptable).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II, Randomized, Double-Blind Pilot Trial of Varenicline (Chantix™) for the Treatment of Alcohol Dependence
The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the treatment of alcohol dependence.
Read the detailed description
By both providing a low level of reinforcement and down-grading any "high" associated with concurrent administration of the abused drug, combined agonist/antagonist therapies promote both initial and sustained abstinence. Based on varenicline's specific affinity for the nicotinic acetylcholine receptors that are implicated in alcohol reward circuitry, it appears to be a good candidate for treatment of alcohol dependence. Alcohol can exert its reinforcing and dopamine-enhancing effects through activation of nicotinic receptors. In addition to its partial agonist activity at heteromeric α4β2 nicotinic acetylcholine receptors, varenicline has also been shown to be a full agonist at homomeric α7 nicotinic acetylcholine receptors. That full agonism at α7 may be key in reducing alcohol withdrawal and craving during early alcohol abstinence, and thus reducing relapse, as α7 receptors are implicated in the neural reward circuitry activated by alcohol use.
- Conditions
- Alcoholism
- Being tested
- varenicline, placebo
- Keywords
- alcohol, treatment, nicotinic acetylcholine receptors, pharmacotherapy, outpatient
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Chantix
1.0 mg BID for 12 weeks
placeboDrug
BID 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: varenicline |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Heavy Drinking Days Per Week.
Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).
Measured: 12 weeks of treatment and one month follow-up
Secondary outcomes (1)
Addiction Severity Index (ASI) Alcohol Composite Score at End of Study.
The Addiction Severity Index (ASI) is a semistructured interview that measures the severity of addiction in 25 questions concerning seven problem areas: medical problems, employment problems, drug use, alcohol use, family and social problems, criminality, and psychiatric problems. Each problem area is measured as its own Compsite Score. Each Composite Score total ranges between 0 (no endorsement of any problems) and 1 (maximal endorsement of all problems). Higher scores (i.e., those closer to 1) on each Composite Score indicate more difficulty/lower functioning in that area, while lower scores (i.e., those closer to 0) indicate higher functioning/less difficulty in that area. As such, the Addiction Severity Index (ASI) Alcohol Composite Total Score must fall between 0 and 1, and scores closer to 1 suggest continued problem drinking.
Measured: 12 weeks of treatment, with a follow-up one month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2010
- Study completionDec 2011
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 University of PennsylvaniaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jennifer Plebani, National Institute on Drug Abuse (NIDA)
- Investigators
- Jennifer G Plebani, PhD, Principal investigator, University of Pennsylvania, Treatment Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705523
- Sponsor's protocol ID
- ChA - 807226
- Other IDs
- P60DA005186
- Acronym
- ChA
- Status last verified
- Jun 2015
- First submitted
- 24 Jun 2008
- Last updated
- 2 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind Pilot Trial of Varenicline (Chantix™) for the Treatment of Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00705523
- Acronym / sponsor ID
- ChA / ChA - 807226
- Conditions
- Alcoholism
- Keywords
- alcohol, treatment, nicotinic acetylcholine receptors, pharmacotherapy, outpatient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Jun 2008 (estimated)
- Results
- Posted 2 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the treatment of alcohol dependence.
Detailed description
By both providing a low level of reinforcement and down-grading any "high" associated with concurrent administration of the abused drug, combined agonist/antagonist therapies promote both initial and sustained abstinence. Based on varenicline's specific affinity for the nicotinic acetylcholine receptors that are implicated in alcohol reward circuitry, it appears to be a good candidate for treatment of alcohol dependence. Alcohol can exert its reinforcing and dopamine-enhancing effects through activation of nicotinic receptors. In addition to its partial agonist activity at heteromeric α4β2 nicotinic acetylcholine receptors, varenicline has also been shown to be a full agonist at homomeric α7 nicotinic acetylcholine receptors. That full agonism at α7 may be key in reducing alcohol withdrawal and craving during early alcohol abstinence, and thus reducing relapse, as α7 receptors are implicated in the neural reward circuitry activated by alcohol use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: varenicline |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Males and females, 18-70 years old.
- 2. Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the SCID-IV (First, 1996).
- 3. Meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell, 1995)
- drank within 30 days of intake day,
- reports a minimum of 48 standard alcoholic drinks (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and
Key exclusion criteria (9 listed)
- Has evidence of dependence on a substance other than alcohol (except nicotine or marijuana); or tests positive on the urine drug screen and on a single allowed retest, during the screening week, with the exception of a THC positive urine, and/or a).positive result for benzodiazepines prescribed by a doctor for medically indicated detox (prescription required).
- Has hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 4.5 times normal after the required 3 days of abstinence, or elevated bilirubin (>1.3) (one retest allowed at the discretion of the Medical Director).
- Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness. For example, bipolar affective disorder, schizophrenia or any other psychotic disorder, or organic mental disorder; has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
- Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication (with the exception of detoxification medications or benadryl used sparingly for sleep).
- Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months, is nursing, or is not using an effective contraceptive method if the subject is of child-bearing potential.
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: Chantix1.0 mg BID for 12 weeks | Drug | 1 |
| placeboBID 12 weeks | Drug | 2 |
Primary outcome
Rate of Heavy Drinking Days Per Week.
Time frame: 12 weeks of treatment and one month follow-up
Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).
1 secondary outcome
Addiction Severity Index (ASI) Alcohol Composite Score at End of Study.
Time frame: 12 weeks of treatment, with a follow-up one month after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- 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.
Jennifer G Plebani, PhD principal investigator
University of Pennsylvania, Treatment Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing varenicline in people with Alcoholism, run by University of Pennsylvania 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?
The sponsor lists 9 inclusion and 9 exclusion criteria. 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: finished, as of the sponsor's last update on 2 Jun 2015. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 Jun 2015). 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?
Rate of Heavy Drinking Days Per Week. (time frame: 12 weeks of treatment and one month follow-up). 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 2 Jun 2015.