Alcohol DependencePhase 2NCT01071187
Varenicline for Alcohol Dependence
A Phase 2 study testing Varenicline in people with Alcohol Dependence, run by Johannes Gutenberg University Mainz at 2 sites in Germany.
Trial summary
The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects. The main study hypothesis is that subjects treated with varenicline have more abstinent days during the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of alcohol dependence according to DSM IV
- inpatient or outpatient
- last alcohol consumption within 7-21 days before randomisation
- subjects must have gone through a detoxification program and must be free of withdrawal symptoms at randomisation
- diagnosis of nicotine dependence according to DSM IV
- sufficient knowledge of the german language
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- subject is able to follow verbal and written instructions
- subject is enabled to consent
- ability of subject to understand character and individual consequences of the clinical trial
- signed and dated informed consent of the subject must bei available before start of any specific trial procedures
- subject must have a clearly stated desire to stay abstinent
- women who are postmenopausal for more than two years or women with childbearing potential who practicing two years can participate in the study
Who cannot join
- alcohol withdrawal delirium during last alcohol detoxification
- alcohol induced dementia
- severe renal insufficiency
- detoxification against subject's will
- women who are pregnant or breastfeeding or planning to become pregnant during the trial
- women with childbearing potential who not practicing a medically accepted contraception during the trial
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- subjects with a known psychiatric disorder requiring treatment including a major depressive disorder, a substance dependence or abuse (besides nicotine, alcohol and cannabis)a psychosis or a dissocial personality disorder according to DSM-IV
- elevated suicide risk, defined as one positive question in the suicide section of the Mini-International Neuropsychiatric Interview (M.I.N.I.)
- subjects with acute depression, defined as a HAMD17 (german version) sum score > 9 or a BDI (german version) sum score > 12
- clinically relevant acute or chronic progressive neurologic, gastrointestinel, cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory disease
- severe infection, a alcohol-induced hepatitis or a uncontrolled arterial hypertension
- use of any medication that can effect on alcohol consumption within 14 days of study initiation including antidepressants, antipsychotics, anticonvulsives, benzodiazepines (besides given in the contect of the detoxification program, anticraving drugs as naltrexone, acamprosate and disulfiram and nicotine substitutes
- subjects with following lab parameters: AST upper fivehold normal limit, PTT < 50%, leucocytes <2/nl, haemoglobin < 9g/dl, thrombocytes < 80/nl, creatinine > 1,5mg/dl and creatinine clearance < 30ml/min
- history of cancer in 5 last years
- known allergy against ingredient of study drug
- history of myocardial infarction or stroke
- participation in a clinical trial during last 90 days prior to screening
- clinically relevant visual disturbance or ear disease
Trial locations and contacts
2 sites in 1 country.
Markus Dr. Lorscheider, clinical coordinator contact
Germany2 sites, 2 recruiting
- Recruiting
Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main
Frankfurt am Main, Hesse, 60431
Christoph Fehr, PD Dr. med., +49-69-9533-4000, Christoph.Fehr@fdk.info
Christoph Fehr, PD Dr. med.
- Recruiting
Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university Mainz
Mainz, Rhineland-Palatinate, 55131
Markus Lorscheider, Dr. med., +49-6131-17-6103, lorscheider@psychiatrie.klinik.uni-mainz.de
Markus Lorscheider, Dr. med.
About this study
Official title: Investigation of the Efficacy and Safety of Varenicline in the Postacute Treatment of Alcohol Dependence - a Prospective, Double-blind, Placebo-controlled, Randomised Phase-II Study
The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects. The main study hypothesis is that subjects treated with varenicline have more abstinent days during the study.
- Conditions
- Alcohol Dependence
- Being tested
- Varenicline, Placebo
- Keywords
- alcohol dependence, addiction, alcohol, relapse prevention
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Varenicline 0,5mg daily on day 1-3, Varenicline 1mg daily on day 4-7 and Varenicline 2mg on day 8-84.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | Treatment with varenicline with 0,5mg daily on day 1-3, 1mg daily on day 4-7 and 2mg daily on day 8-84. Receives: Drug: Varenicline |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days
Measured: 12 weeks
Secondary outcomes (16)
Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview
Measured: 12 weeks
Proportion of abstinent patients during the study, percentage of all patients
Measured: 12 weeks
Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview.
Measured: 12 weeks
Time in days to first heavy drinking, assessed by the time-line-follow-back-interview.
Measured: 12 weeks
Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview.
Measured: 12 weeks
Changes in gamma-glutamyl transpeptidase levels
Measured: 12 weeks
Occurrence of adverse events
Measured: 12 weeks
Compliance of the subjects
Measured: 12 weeks
alcohol craving assessed by the obsessive compulsive drinking scale (OCDS) and a visual analog scale (VAS)
Measured: 12 weeks
Severity of the alcohol dependence assessed by the European Addiction Severity Index (EuropASI)
Measured: 12 weeks
Absolute change in the Clinical Global Impression of Change (CGI)
Measured: 12 weeks
Quality of life, assessed by the questionnaire for health condition Fragebogen zum allgemeinen Gesundheitszustand (SF-12)
Measured: 12 weeks
Number of cigarettes per day
Measured: 12 weeks
Number of nicotine abstinent days, percentage of the treatment days
Measured: 12 weeks
Severity of the nicotine dependence, assessed by the Fagerstrom test for nicotine dependence
Measured: 12 weeks
Intensity of depressive symptoms, assessed by the Beck Depression Inventors (BDI)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Fehr Christoph, PD Dr., Principal investigator, Department of psychiatry and psychotherapy, university medical center mainz of the Johannes Gutenberg-university mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071187
- Sponsor's protocol ID
- 2009-08-17
- Other IDs
- 2009-015537-67, 2009
- Status last verified
- Sep 2010
- First submitted
- 18 Feb 2010
- Last updated
- 15 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy and Safety of Varenicline in the Postacute Treatment of Alcohol Dependence - a Prospective, Double-blind, Placebo-controlled, Randomised Phase-II Study
- ClinicalTrials.gov ID
- NCT01071187
- Acronym / sponsor ID
- 2009-08-17
- Conditions
- Alcohol Dependence
- Keywords
- alcohol dependence, addiction, alcohol, relapse prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects. The main study hypothesis is that subjects treated with varenicline have more abstinent days during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: VareniclineTreatment with varenicline with 0,5mg daily on day 1-3, 1mg daily on day 4-7 and 2mg daily on day 8-84. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- diagnosis of alcohol dependence according to DSM IV
- inpatient or outpatient
- last alcohol consumption within 7-21 days before randomisation
- subjects must have gone through a detoxification program and must be free of withdrawal symptoms at randomisation
- diagnosis of nicotine dependence according to DSM IV
Key exclusion criteria (18 listed)
- alcohol withdrawal delirium during last alcohol detoxification
- alcohol induced dementia
- severe renal insufficiency
- detoxification against subject's will
- women who are pregnant or breastfeeding or planning to become pregnant during the trial
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 |
|---|---|---|
| VareniclineVarenicline 0,5mg daily on day 1-3, Varenicline 1mg daily on day 4-7 and Varenicline 2mg on day 8-84. | Drug | Varenicline |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days
Time frame: 12 weeks
16 secondary outcomes
Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview
Time frame: 12 weeks
Proportion of abstinent patients during the study, percentage of all patients
Time frame: 12 weeks
Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview.
Time frame: 12 weeks
Time in days to first heavy drinking, assessed by the time-line-follow-back-interview.
Time frame: 12 weeks
Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview.
Time frame: 12 weeks
Changes in gamma-glutamyl transpeptidase levels
Time frame: 12 weeks
Occurrence of adverse events
Time frame: 12 weeks
Compliance of the subjects
Time frame: 12 weeks
alcohol craving assessed by the obsessive compulsive drinking scale (OCDS) and a visual analog scale (VAS)
Time frame: 12 weeks
Severity of the alcohol dependence assessed by the European Addiction Severity Index (EuropASI)
Time frame: 12 weeks
Absolute change in the Clinical Global Impression of Change (CGI)
Time frame: 12 weeks
Quality of life, assessed by the questionnaire for health condition Fragebogen zum allgemeinen Gesundheitszustand (SF-12)
Time frame: 12 weeks
Number of cigarettes per day
Time frame: 12 weeks
Number of nicotine abstinent days, percentage of the treatment days
Time frame: 12 weeks
Severity of the nicotine dependence, assessed by the Fagerstrom test for nicotine dependence
Time frame: 12 weeks
Intensity of depressive symptoms, assessed by the Beck Depression Inventors (BDI)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2010.
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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.
Markus Dr. Lorscheider, clinical coordinator contact
Fehr Christoph, PD Dr. principal investigator
Department of psychiatry and psychotherapy, university medical center mainz of the Johannes Gutenberg-university mainz
2 sites 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 Alcohol Dependence, run by Johannes Gutenberg University Mainz at 2 sites in Germany.
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 12 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 15 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Dr. Lorscheider, clinical coordinator (+496131176103, lorscheider@psychiatrie.klinik.uni-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days (time frame: 12 weeks). 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 15 Sep 2010.