Substance DependenceNCT01011907
A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence
A study testing varenicline in people with Substance Dependence, run by University of California, San Francisco at 1 site in United States.
Trial summary
Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which either varenicline (twice daily) or placebo will be administered over a 12 week study period to examine genetic influences on treatment response to varenicline for reduction of hazardous drinking. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Substance Dependence
- What is being tested?
- varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2012
- Phase
- Interventional
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 and 75 years.
- Currently seeking treatment for nicotine dependence (smoke at least 10 cigarettes daily) and found to have problem drinking, alcohol abuse or alcohol dependence (non-physiological) as determined by amount of alcohol consumed weekly (Average weekly alcohol consumption (last 30 days), >7 standard drinks (for women) or >14 standard drinks (for men), clinical interview, and AUDIT score > 8.
- Generally healthy, without serious or unstable medical/mental illness(es).
- Smokers only will be included (degree of nicotine dependence will be assessed and included in analysis).
- Able to give voluntary, written, informed consent
Who cannot join
- More than 30 days of abstinence from alcohol in the prior 90 days.
- History of major alcohol-related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, liver function tests > 3 X ULN).
- Intolerance to the study medication.
- Current psychiatric disorder(s) requiring clinical treatment.
- Any recent history (i.e. within the preceding 5 years) of suicide attempt or current suicidal ideation.
- Use of illicit or non-prescribed psychotropic drug use (opiates, benzodiazepines, cocaine, PCP, methamphetamine, cocaine, or marijuana more than twice a week).
- A history of complicated alcohol or other drug withdrawal syndrome(s), e.g.: delirium tremens or seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF: Ernest Gallo Clinic and Research Center
Emeryville, California, 94608
About this study
Official title: Characterizing Alpha5 Nicotinic Receptors in Alcohol and Nicotine Dependence
Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which either varenicline (twice daily) or placebo will be administered over a 12 week study period to examine genetic influences on treatment response to varenicline for reduction of hazardous drinking.
Read the detailed description
Hazardous alcohol use and alcohol use disorders (AUDs) are an area of large unmet medical needs. Although there has been some progress with pharmacotherapy for alcohol-dependent individuals, a critical need for the development of novel and additional therapeutic approaches remains. Pharmacotherapy development for AUDs as a therapeutic area has had several recent advancements, where clinically as well as commercially successful additions to available treatment options are available and several more are expected in the near future. Based on recent preclinical work, we believe that varenicline has potential to become one of the first among those newly evolving treatments.
In this study, participants with nicotine dependence will receive standard varenicline or placebo treatment over the recommended course of 12 weeks. Since our research question addresses whether alcohol drinking also diminishes with varenicline treatment, we will not ask participants to alter alcohol use; we will simply follow their use over time. Study visits will take place at the Ernest Gallo Clinic and Research Center. The procedures to be completed include vital signs, blood samples at screening and end of study, urine toxicology screening and the completion of standard questionnaires. No special facilities are required for these procedures. Group therapy (which is not a research procedure, but part of standard nicotine dependence treatment) will take place at the Gallo Center.
- Conditions
- Substance Dependence
- Being tested
- varenicline, placebo
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Chantix
12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
placeboDrug
12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
| Study group | Role | What they receive |
|---|---|---|
| varenicline | Experimental | Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). Receives: Drug: varenicline |
| placebo | Placebo comparator | Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily). Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.
Measured: Weeks 1-12
Secondary outcomes (2)
Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12.
Measured: Weeks 1-12
Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study.
Higher scores on the OCDS indicate increased craving. OCDS possible score range = 0 - 40. Difference in average OCDS scores from week 1 to week 12 were reported for the varenicline and placebo groups in subjects that completed the study.
Measured: Week 1 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionJun 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance DependenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Howard Fields, MD PhD, Principal investigator, UCSF: Ernest Gallo CLinic and Research CenterJennifer Mitchell, PhD, Study director, UCSF: Ernest Gallo Clinic and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011907
- Sponsor's protocol ID
- EGCRC0109
- Other IDs
- RC2AA019429
- Status last verified
- Feb 2013
- First submitted
- 9 Nov 2009
- Last updated
- 25 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mitchell JM, Teague CH, Kayser AS, Bartlett SE, Fields HL. Varenicline decreases alcohol consumption in heavy-drinking smokers. Psychopharmacology (Berl). 2012 Oct;223(3):299-306. doi: 10.1007/s00213-012-2717-x. Epub 2012 May 1.
PubMed 22547331
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Alpha5 Nicotinic Receptors in Alcohol and Nicotine Dependence
- ClinicalTrials.gov ID
- NCT01011907
- Acronym / sponsor ID
- EGCRC0109
- Conditions
- Substance Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Posted 25 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which either varenicline (twice daily) or placebo will be administered over a 12 week study period to examine genetic influences on treatment response to varenicline for reduction of hazardous drinking.
Detailed description
Hazardous alcohol use and alcohol use disorders (AUDs) are an area of large unmet medical needs. Although there has been some progress with pharmacotherapy for alcohol-dependent individuals, a critical need for the development of novel and additional therapeutic approaches remains. Pharmacotherapy development for AUDs as a therapeutic area has had several recent advancements, where clinically as well as commercially successful additions to available treatment options are available and several more are expected in the near future. Based on recent preclinical work, we believe that varenicline has potential to become one of the first among those newly evolving treatments.
In this study, participants with nicotine dependence will receive standard varenicline or placebo treatment over the recommended course of 12 weeks. Since our research question addresses whether alcohol drinking also diminishes with varenicline treatment, we will not ask participants to alter alcohol use; we will simply follow their use over time. Study visits will take place at the Ernest Gallo Clinic and Research Center. The procedures to be completed include vital signs, blood samples at screening and end of study, urine toxicology screening and the completion of standard questionnaires. No special facilities are required for these procedures. Group therapy (which is not a research procedure, but part of standard nicotine dependence treatment) will take place at the Gallo Center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varenicline | Experimental | Drug: vareniclineDrug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). |
| placebo | Placebo comparator | Drug: placeboDrug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily). |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 21 and 75 years.
- Currently seeking treatment for nicotine dependence (smoke at least 10 cigarettes daily) and found to have problem drinking, alcohol abuse or alcohol dependence (non-physiological) as determined by amount of alcohol consumed weekly (Average weekly alcohol consumption (last 30 days), >7 standard drinks (for women) or >14 standard drinks (for men), clinical interview, and AUDIT score > 8.
- Generally healthy, without serious or unstable medical/mental illness(es).
- Smokers only will be included (degree of nicotine dependence will be assessed and included in analysis).
- Able to give voluntary, written, informed consent
Key exclusion criteria (7 listed)
- More than 30 days of abstinence from alcohol in the prior 90 days.
- History of major alcohol-related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, liver function tests > 3 X ULN).
- Intolerance to the study medication.
- Current psychiatric disorder(s) requiring clinical treatment.
- Any recent history (i.e. within the preceding 5 years) of suicide attempt or current suicidal ideation.
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: Chantix12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). | Drug | varenicline |
| placebo12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily). | Drug | placebo |
Primary outcome
Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.
Time frame: Weeks 1-12
2 secondary outcomes
Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12.
Time frame: Weeks 1-12
Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study.
Time frame: Week 1 to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22547331Mitchell JM, Teague CH, Kayser AS, Bartlett SE, Fields HL. Varenicline decreases alcohol consumption in heavy-drinking smokers. Psychopharmacology (Berl). 2012 Oct;223(3):299-306. doi: 10.1007/s00213-012-2717-x. Epub 2012 May 1.
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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.
Howard Fields, MD PhD principal investigator
UCSF: Ernest Gallo CLinic and Research Center
Jennifer Mitchell, PhD study director
UCSF: Ernest Gallo Clinic and Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing varenicline in people with Substance Dependence, run by University of California, San Francisco 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 5 inclusion and 7 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 25 Feb 2013. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 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?
Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12. (time frame: Weeks 1-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01011907, which also lists 1 linked publication.
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 25 Feb 2013.