Alcohol DependencePhase 2NCT00183235
Aripiprazole Effects on Alcohol Reactivity and Consumption
A Phase 2 study testing aripiprazole (up to 15 mg/day) for 8 days in people with Alcohol Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer) is effective in reducing of alcohol craving compared to placebo. 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?
- aripiprazole (up to 15 mg/day) for 8 days
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Feb 2006
- 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
- Age 21 - 65
- Meets the DSM IV criterion for current alcohol dependence including "loss of control over drinking" (criterion 3 and/or 4).
- Currently is not engaged in, and does not want treatment for, alcohol related problems.
- Able to read and understand questionnaires and informed consent.
- Lives within 50 miles of the study site.
- Able to maintain abstinence for up to two days (without the aid of detox medications) as determined by self report and breathalyzer measurements.
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- *Inclusion for fMRI imaging:
- Does not have metal objects in the head/neck.
- Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.
Who cannot join
- Currently meets DSM IV criteria for any other psychoactive substance dependence disorder.
- Any psychoactive substance use (except marijuana and nicotine) within the last 30 days as evidenced by self-report and urine drug screen. For marijuana - no use within the last seven days.
- Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders and eating disorders, any other psychotic disorder or organic mental disorder.
- Has current suicidal ideation or homicidal ideation.
- Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications.
- Current use of disulfiram.
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- Clinically significant medical problems such as, cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion.
- Past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.
- Hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2 1/2 times normal at screening.
- Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
- Has current charges pending for a violent crime (not including DUI related offenses).
- Does not have a stable living situation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Drug and Alcohol Programs, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Effectiveness of Aripiprazole to Reduce Craving for Alcohol and Drinking Under Natural Observation, During Cue Induced Brain Imaging, and During a Motivated Free Choice Drinking Procedure Compared to Placebo
The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer) is effective in reducing of alcohol craving compared to placebo.
Read the detailed description
Non-treatment seeking individuals meeting criteria for alcohol dependence (N=30) will be recruited through advertisement and paid for their participation. Alcoholics, after baseline evaluation, will be assigned through urn randomization to one of two experimental groups in which they will receive either aripiprazole (up to 15 mg/day) or an identical placebo. Subjects will take the study drug or placebo for 8 days (day 1-6 being the natural observation period). After a minimum of 24 hours of abstinence from alcohol (day 7-8) they will undergo an alcohol administration (priming dose) and motivated free choice drinking procedure (on day 8). Alcoholic subjects will receive a brief counseling session at the end of the study to enhance their awareness of problem drinking and to motivate them to seek treatment. Referral for treatment will be offered.
Each subject will undergo a functional MRI brain scan with cue stimulation on day 7, on the evening before the alcohol administration paradigm. fMRI brain imaging technology will be used to determine if alcoholics treated with aripiprazole differ in alcohol cue-induced activity in the nucleus accumbens. It is hypothesized that aripiprazole will reduce nucleus accumbens activation to alcohol cues compared to placebo.
- Conditions
- Alcohol Dependence
- Being tested
- aripiprazole (up to 15 mg/day) for 8 days
- Keywords
- Alcohol dependence, Alcoholism, Craving
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazole (up to 15 mg/day) for 8 daysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
For the Efficacy Hypotheses, the primary dependent variables are
(First) "Natural" alcohol consumption period -- total number of drinks consumed during the 5-day observation period
(Second) Limited access alcohol consumption paradigm -- Total number of drinks consumed
(Third) Activation of nucleus accumbens after cue stimulation
For the Safety and Tolerability Hypotheses, the primary dependent variables are
(First) Number of drop-outs due to adverse events
(Second) Number of side effects on symptom checklist
(Third) Change in liver function as indicated by ALT, AST
Secondary outcomes (8)
Blood alcohol levels after priming drink
Average BAES stimulation score
SHAS score after alcohol priming drink
Change in POMS sub-scale scores
Change in Epworth Sleepiness Scale
Differential effects on the Quality of Sleep Scale
Craving (OCDS) change between day 1 and 6
Craving after alcohol priming
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2005
- Study completionFeb 2006
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.
- More trials run by Medical University of South CarolinaThe 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
- Factorial
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Raymond F. Anton, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183235
- Sponsor's protocol ID
- NIAAAANT010761-2005b
- Other IDs
- P50AA010761, NIH P50 AA010761
- Status last verified
- May 2010
- First submitted
- 13 Sep 2005
- Last updated
- 5 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aripiprazole to Reduce Craving for Alcohol and Drinking Under Natural Observation, During Cue Induced Brain Imaging, and During a Motivated Free Choice Drinking Procedure Compared to Placebo
- ClinicalTrials.gov ID
- NCT00183235
- Acronym / sponsor ID
- NIAAAANT010761-2005b
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol dependence, Alcoholism, Craving
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jun 2005
- Study completion
- Feb 2006 (actual)
- First posted
- 16 Sep 2005 (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 purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer) is effective in reducing of alcohol craving compared to placebo.
Detailed description
Non-treatment seeking individuals meeting criteria for alcohol dependence (N=30) will be recruited through advertisement and paid for their participation. Alcoholics, after baseline evaluation, will be assigned through urn randomization to one of two experimental groups in which they will receive either aripiprazole (up to 15 mg/day) or an identical placebo. Subjects will take the study drug or placebo for 8 days (day 1-6 being the natural observation period). After a minimum of 24 hours of abstinence from alcohol (day 7-8) they will undergo an alcohol administration (priming dose) and motivated free choice drinking procedure (on day 8). Alcoholic subjects will receive a brief counseling session at the end of the study to enhance their awareness of problem drinking and to motivate them to seek treatment. Referral for treatment will be offered.
Each subject will undergo a functional MRI brain scan with cue stimulation on day 7, on the evening before the alcohol administration paradigm. fMRI brain imaging technology will be used to determine if alcoholics treated with aripiprazole differ in alcohol cue-induced activity in the nucleus accumbens. It is hypothesized that aripiprazole will reduce nucleus accumbens activation to alcohol cues compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 21 - 65
- Meets the DSM IV criterion for current alcohol dependence including "loss of control over drinking" (criterion 3 and/or 4).
- Currently is not engaged in, and does not want treatment for, alcohol related problems.
- Able to read and understand questionnaires and informed consent.
- Lives within 50 miles of the study site.
Key exclusion criteria (12 listed)
- Currently meets DSM IV criteria for any other psychoactive substance dependence disorder.
- Any psychoactive substance use (except marijuana and nicotine) within the last 30 days as evidenced by self-report and urine drug screen. For marijuana - no use within the last seven days.
- Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders and eating disorders, any other psychotic disorder or organic mental disorder.
- Has current suicidal ideation or homicidal ideation.
- Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications.
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 |
|---|---|---|
| aripiprazole (up to 15 mg/day) for 8 days | Drug | – |
Primary outcome
For the Efficacy Hypotheses, the primary dependent variables are
(First) "Natural" alcohol consumption period -- total number of drinks consumed during the 5-day observation period
(Second) Limited access alcohol consumption paradigm -- Total number of drinks consumed
(Third) Activation of nucleus accumbens after cue stimulation
For the Safety and Tolerability Hypotheses, the primary dependent variables are
(First) Number of drop-outs due to adverse events
(Second) Number of side effects on symptom checklist
(Third) Change in liver function as indicated by ALT, AST
8 secondary outcomes
Blood alcohol levels after priming drink
Average BAES stimulation score
SHAS score after alcohol priming drink
Change in POMS sub-scale scores
Change in Epworth Sleepiness Scale
Differential effects on the Quality of Sleep Scale
Craving (OCDS) change between day 1 and 6
Craving after alcohol priming
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 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.
Raymond F. Anton, MD principal investigator
Medical University of South Carolina
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 aripiprazole (up to 15 mg/day) for 8 days in people with Alcohol Dependence, run by Medical University of South Carolina 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 12 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 5 May 2010. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
For the Efficacy Hypotheses, the primary dependent variables are. The study lists 8 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 5 May 2010.