AlcoholismPhase 2NCT00674765
Seroquel for Frequent, Heavy Drinkers
A Phase 2 study testing Seroquel in people with Alcoholism, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of quetiapine in reducing percent heavy drinking days and increasing percent abstinent days in alcohol dependent patients who are frequent heavy drinkers. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Seroquel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2014
- 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
- Male and females, 18-70 years old.
- Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the MINI/SCID-IV {First, 1996 #34}.
- Meets the drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992 #37}:
- Three consecutive days of abstinence from alcohol immediately before randomization
- 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 and marijuana).
- Tests positive on the urine drug screen during the screening weeks (one retest allowed). Subjects whose urine drug screen tests positive for benzodiazepines will be allowed to randomize, at the discretion of the PI, if they are known to be physician-prescribed for detox purposes.
- 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), with associated elevations of AST and ALT above normal limits.
- Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness.
- 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.
Show all 11Show fewer
- 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 patient is of child-bearing potential, meaning has not had a hysterectomy or is in menopause, meaning 50 or over and has not had a menstrual cycle in 12 months.
- Has known hypersensitivity to antipsychotics.
- Has taken any investigational drug as part of an investigational trial within 30 days prior to the randomization.
- A history of seizure disorder.
- The presence of cataracts.
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 Double-blind, Placebo-controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2)
The purpose of this study is to examine the effects of quetiapine in reducing percent heavy drinking days and increasing percent abstinent days in alcohol dependent patients who are frequent heavy drinkers.
Read the detailed description
This trial is a phase 2, randomized, double-blind, placebo-controlled, parallel group trial intended to assess the efficacy of quetiapine compared to placebo in alcoholics who are frequent heavy drinkers.
- Conditions
- Alcoholism
- Being tested
- Seroquel, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeroquelDrug
Also called quetiapine
400 mg/day
PlaceboDrug
400 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Seroquel Receives: Drug: Seroquel |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase
The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm.
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 posted8 May 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionJan 2014
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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Kyle M Kampman, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674765
- Sponsor's protocol ID
- 807057 - Kampan_AA016553
- Other IDs
- NIH Grant 1R01AA016553-01A1
- Status last verified
- Sep 2014
- First submitted
- 6 May 2008
- Last updated
- 17 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-blind, Placebo-controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2)
- ClinicalTrials.gov ID
- NCT00674765
- Acronym / sponsor ID
- 807057 - Kampan_AA016553
- Conditions
- Alcoholism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Posted 17 Sep 2014
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 examine the effects of quetiapine in reducing percent heavy drinking days and increasing percent abstinent days in alcohol dependent patients who are frequent heavy drinkers.
Detailed description
This trial is a phase 2, randomized, double-blind, placebo-controlled, parallel group trial intended to assess the efficacy of quetiapine compared to placebo in alcoholics who are frequent heavy drinkers.
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 | Experimental | Drug: SeroquelSeroquel |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and females, 18-70 years old.
- Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the MINI/SCID-IV {First, 1996 #34}.
- Meets the drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992 #37}:
- Three consecutive days of abstinence from alcohol immediately before randomization
- Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
Key exclusion criteria (11 listed)
- Has evidence of dependence on a substance other than alcohol (except nicotine and marijuana).
- Tests positive on the urine drug screen during the screening weeks (one retest allowed). Subjects whose urine drug screen tests positive for benzodiazepines will be allowed to randomize, at the discretion of the PI, if they are known to be physician-prescribed for detox purposes.
- 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), with associated elevations of AST and ALT above normal limits.
- Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness.
- Has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
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 |
|---|---|---|
| SeroquelAlso: quetiapine400 mg/day | Drug | 1 |
| Placebo400 mg/day | Drug | 2 |
Primary outcome
TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase
Time frame: 12 weeks
The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Alcoholism
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Recruiting
Coordinated Care for Alcohol Problems
Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Enrolling by invitationObservational study
Addictions Neuroclinical Assessment (ANA)
Normal Physiology, Alcohol Use Disorder
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.
Kyle M Kampman, M.D. principal investigator
University of Pennsylvania
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 Seroquel 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 6 inclusion and 11 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 17 Sep 2014. 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 17 Sep 2014). 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?
TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase (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 17 Sep 2014.