Alcohol DependencePhase 2NALAPZNCT00667875
An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
A Phase 2 study testing Naltrexone and Naltrexone + Aripiprazole in people with Alcohol Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Naltrexone and Naltrexone + Aripiprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 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
- Age 18 70
- Subjects will meet criteria for primary alcohol dependence operationalized as follows:
- Meets the DSM IV criteria for alcohol dependence including loss of control over drinking (criterion 3) B. Has not had more than one previous inpatient medical detoxification
- Consumes, on average, at least 10 standard drinks per drinking day for men and 8 drinks per day for women in the 90 days pre-screening (to select an appropriately heavy drinking population)
- Able to maintain sobriety for four days (with or without the aid of alcohol detoxification medications) as determined by self report, collateral report, and breathalyzer measurements
- Able to read and understand questionnaires and informed consent
- Lives within approximately 50 miles of the study site -
Who cannot join
- Currently meets DSM IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
- Ever abused opiates
- Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen
- 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, or any other psychotic disorder or organic mental disorder
- Meets DSM IV current criteria for dissociative disorder or eating disorders
- Has current suicidal ideation or homicidal ideation
Show all 15Show fewer
- Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications
- Current use of disulfiram
- Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
- Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days abstinence
- Sexually active female of child-bearing potential who is pregnant (by urine HCG), nursing, or who is 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 and a reliable source of collateral reporting
- Has taken an opiate antagonist drug in the last month
- Has taken aripiprazole in the last month or has experienced adverse effects from it at any time in the past
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina, Center for Drug and Alcohol Programs
Charleston, South Carolina, 29425
About this study
The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.
- Conditions
- Alcohol Dependence
- Being tested
- Placebo, Naltrexone, Naltrexone + Aripiprazole
- Keywords
- Alcohol Dependence, Alcoholism, Naltrexone, Aripiprazole, Substance Abuse
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo
NaltrexoneDrug
Naltrexone (25mg or 50 mg per titration schedule)
Naltrexone + AripiprazoleDrug
Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Active comparator | Naltrexone Receives: Drug: Naltrexone |
| 3 | Active comparator | Naltrexone + Aripiprazole Receives: Drug: Naltrexone + Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks Per Drinking Day
Standard drinks per drinking day
Measured: 16-week treatment period
Percent Heavy Drinking Days
percent of total 112 day trial in which heavy drinking occurred (>=4 for females, >=5 male)
Measured: 16 weeks
Secondary outcomes (2)
Pill Counts During Treatment
Compliance with medication as determined by pill counts
Measured: 16-week
Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance
Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime
Measured: 16 weeks treatment trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2011
- Study completionMay 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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
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)
- Responsible party
- Principal investigator, Raymond F. Anton, Medical University of South Carolina
- Investigators
- Raymond F Anton, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667875
- Sponsor's protocol ID
- ANTON-1R21AA017525-01
- Other IDs
- R21AA017525, NIH Grant AA017525-01
- Acronym
- NALAPZ
- Status last verified
- Aug 2017
- First submitted
- 24 Apr 2008
- Last updated
- 29 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00667875
- Acronym / sponsor ID
- NALAPZ / ANTON-1R21AA017525-01
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol Dependence, Alcoholism, Naltrexone, Aripiprazole, Substance Abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 18 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Active comparator | Drug: NaltrexoneNaltrexone |
| 3 | Active comparator | Drug: Naltrexone + AripiprazoleNaltrexone + Aripiprazole |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 70
- Subjects will meet criteria for primary alcohol dependence operationalized as follows:
- Consumes, on average, at least 10 standard drinks per drinking day for men and 8 drinks per day for women in the 90 days pre-screening (to select an appropriately heavy drinking population)
- Able to maintain sobriety for four days (with or without the aid of alcohol detoxification medications) as determined by self report, collateral report, and breathalyzer measurements
- Able to read and understand questionnaires and informed consent
Key exclusion criteria (15 listed)
- Currently meets DSM IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
- Ever abused opiates
- Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen
- 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, or any other psychotic disorder or organic mental disorder
- Meets DSM IV current criteria for dissociative disorder or eating disorders
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 |
|---|---|---|
| Placeboplacebo | Drug | 1 |
| NaltrexoneNaltrexone (25mg or 50 mg per titration schedule) | Drug | 2 |
| Naltrexone + AripiprazoleNaltrexone + Aripiprazole (5mg - 15mg per titration schedule) | Drug | 3 |
Primary outcome
Drinks Per Drinking Day
Time frame: 16-week treatment period
Standard drinks per drinking day
Percent Heavy Drinking Days
Time frame: 16 weeks
percent of total 112 day trial in which heavy drinking occurred (>=4 for females, >=5 male)
2 secondary outcomes
Pill Counts During Treatment
Time frame: 16-week
Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance
Time frame: 16 weeks treatment trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- 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.
Raymond F Anton, M.D. 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 Naltrexone and Naltrexone + Aripiprazole 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 7 inclusion and 15 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 29 Sep 2017. 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 18 Apr 2016). 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?
Drinks Per Drinking Day (time frame: 16-week treatment period). The study lists 2 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 29 Sep 2017.