AlcoholismPhase 4NCT00369408
Targeted Naltrexone for Problem Drinkers
A Phase 4 study testing Naltrexone in people with Alcoholism and Alcohol Drinking, run by UConn Health at 1 site in United States.
Trial summary
The purpose of this study is to determine whether naltrexone, combined with brief coping skills therapy, is effective in the treatment of heavy drinking. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholism, Alcohol Drinking, Alcohol Dependence
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Mar 2008
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female outpatients 18-70 years of age.
- Participants will have an average weekly ethanol consumption of >=24 standard drinks for men, or >=18 standard drinks for women (i.e., substantially in excess of non-hazardous drinking levels).
- Participants will be able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.
- If a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or who are less than two years postmenopausal), participant must be non-lactating, practicing a reliable method of birth control, and have a negative serum pregnancy test prior to initiation of treatment.
- Participants will be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels).
Who cannot join
- Participants who have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including total bilirubin elevations of >110% or ALT or AST elevations >300% the upper limit of normal or have a diagnosis of Hepatitis B or C infection or AIDS (given the potential for adverse effects of naltrexone on liver function).
- Participants who have a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality states, organic mood or mental disorders, or substantial suicide or violence risk) on the basis of history or psychiatric examination.
- Participants who have a current Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) diagnosis of drug dependence (other than nicotine dependence) or a lifetime DSM-IV diagnosis of opioid dependence.
- Participants who have a current DSM-IV diagnosis of alcohol dependence that is clinically severe.
- Participants who have used opioids or other psychoactive medications regularly in the month prior to study enrollment.
- Participants who have a history of hypersensitivity to naltrexone.
- Participants who are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
The purpose of this study is to determine whether naltrexone, combined with brief coping skills therapy, is effective in the treatment of heavy drinking.
Read the detailed description
This is a 12-week, placebo-controlled trial of naltrexone (50 mg orally) in 163 problem drinkers. Problem drinkers are those individuals whose drinking puts them at risk of a variety of psychosocial and medical problems, including alcohol dependence, but who are not physically dependent on alcohol. They are estimated to comprise up to 20% of the general population. The study employed a factorial design in which the effects of medication (naltrexone vs. placebo), schedule of medication administration (i.e., daily vs. targeted), and the interaction of these factors on drinking behavior were examined. Targeted administration refers to the use of medication to cope with anticipated high-risk drinking situations.
The daily monitoring using interactive voice response technology of mood, desire to drink, perceived self-efficacy, and drinking behavior will make it possible to examine in depth the processes by which the study variables exert their effects. Daily monitoring was performed using automated telephone interviews, with in-person follow-up evaluations conducted at 3 and 6 months post-treatment to provide a measure of the durability of treatment effects.
A pharmacogenetic analysis based on preliminary evidence showing that a functional polymorphism in the gene encoding the mu-opioid receptor (OPRM1) affects response to naltrexone will serve to explore an important source of variation in the response to naltrexone treatment. Exploratory analyses involving other potential genetic moderators of the response to naltrexone, such as the gene encoding the delta opioid receptor (OPRD1), will also be conducted, as will the correlation of genotype data with other phenotypes.
Careful evaluation of the study hypotheses will provide important information on the efficacy and mechanism of the effects of targeted naltrexone in problem drinkers. This study will allow us to model effects across multiple levels of analysis in an effort to understand the psychopharmacological mechanisms underlying the therapeutic effects of naltrexone in problem drinkers and to apply novel genetic findings to understanding the pharmacogenetic mechanisms underlying the therapeutic effects of naltrexone in problem drinkers.
- Conditions
- Alcoholism, Alcohol Drinking, Alcohol Dependence
- Being tested
- Naltrexone, placebo
- Keywords
- Randomized Trial, Medication for Heavy Drinking, Naltrexone Treatment, Daily vs. Targeted Administration
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called ReVia
naltrexone (50 mg orally) for 12-week treatment period; 3 and 6 months post-treatment follow-up
placeboDrug
placebo for 12-week treatment period; 3 and 6 months post-treatment follow-up
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | naltrexone (50 mg orally) for 12-week treatment period Receives: Drug: Naltrexone |
| 2 | Placebo comparator | placebo for 12-week treatment period Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking days and heavy drinking days
Measured: 12-week trial; 3 and 6 months post-treatment follow-up
Secondary outcomes (2)
Alcohol-related problems
Measured: 12-week trial; 3 and 6 months post-treatment follow-up
Biological measures of alcohol consumption (i.e., serum GGTP and CDT)
Measured: 12-week trial; 3 and 6 months post-treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startJun 2003
- Primary completionAug 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Henry R. Kranzler, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369408
- Sponsor's protocol ID
- 03-107-2
- Other IDs
- NIAAA-KRA-P50-03510
- Status last verified
- Jun 2011
- First submitted
- 24 Aug 2006
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kranzler HR, Tennen H, Armeli S, Chan G, Covault J, Arias A, Oncken C. Targeted naltrexone for problem drinkers. J Clin Psychopharmacol. 2009 Aug;29(4):350-7. doi: 10.1097/JCP.0b013e3181ac5213.
PubMed 19593174
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Naltrexone for Problem Drinkers
- ClinicalTrials.gov ID
- NCT00369408
- Acronym / sponsor ID
- 03-107-2
- Conditions
- Alcoholism, Alcohol Drinking, Alcohol Dependence
- Keywords
- Randomized Trial, Medication for Heavy Drinking, Naltrexone Treatment, Daily vs. Targeted Administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jun 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Aug 2006 (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 naltrexone, combined with brief coping skills therapy, is effective in the treatment of heavy drinking.
Detailed description
This is a 12-week, placebo-controlled trial of naltrexone (50 mg orally) in 163 problem drinkers. Problem drinkers are those individuals whose drinking puts them at risk of a variety of psychosocial and medical problems, including alcohol dependence, but who are not physically dependent on alcohol. They are estimated to comprise up to 20% of the general population. The study employed a factorial design in which the effects of medication (naltrexone vs. placebo), schedule of medication administration (i.e., daily vs. targeted), and the interaction of these factors on drinking behavior were examined. Targeted administration refers to the use of medication to cope with anticipated high-risk drinking situations.
The daily monitoring using interactive voice response technology of mood, desire to drink, perceived self-efficacy, and drinking behavior will make it possible to examine in depth the processes by which the study variables exert their effects. Daily monitoring was performed using automated telephone interviews, with in-person follow-up evaluations conducted at 3 and 6 months post-treatment to provide a measure of the durability of treatment effects.
A pharmacogenetic analysis based on preliminary evidence showing that a functional polymorphism in the gene encoding the mu-opioid receptor (OPRM1) affects response to naltrexone will serve to explore an important source of variation in the response to naltrexone treatment. Exploratory analyses involving other potential genetic moderators of the response to naltrexone, such as the gene encoding the delta opioid receptor (OPRD1), will also be conducted, as will the correlation of genotype data with other phenotypes.
Careful evaluation of the study hypotheses will provide important information on the efficacy and mechanism of the effects of targeted naltrexone in problem drinkers. This study will allow us to model effects across multiple levels of analysis in an effort to understand the psychopharmacological mechanisms underlying the therapeutic effects of naltrexone in problem drinkers and to apply novel genetic findings to understanding the pharmacogenetic mechanisms underlying the therapeutic effects of naltrexone in problem drinkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Naltrexonenaltrexone (50 mg orally) for 12-week treatment period |
| 2 | Placebo comparator | Drug: placeboplacebo for 12-week treatment period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female outpatients 18-70 years of age.
- Participants will have an average weekly ethanol consumption of >=24 standard drinks for men, or >=18 standard drinks for women (i.e., substantially in excess of non-hazardous drinking levels).
- Participants will be able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.
- If a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or who are less than two years postmenopausal), participant must be non-lactating, practicing a reliable method of birth control, and have a negative serum pregnancy test prior to initiation of treatment.
- Participants will be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels).
Key exclusion criteria (7 listed)
- Participants who have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including total bilirubin elevations of >110% or ALT or AST elevations >300% the upper limit of normal or have a diagnosis of Hepatitis B or C infection or AIDS (given the potential for adverse effects of naltrexone on liver function).
- Participants who have a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality states, organic mood or mental disorders, or substantial suicide or violence risk) on the basis of history or psychiatric examination.
- Participants who have a current Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) diagnosis of drug dependence (other than nicotine dependence) or a lifetime DSM-IV diagnosis of opioid dependence.
- Participants who have a current DSM-IV diagnosis of alcohol dependence that is clinically severe.
- Participants who have used opioids or other psychoactive medications regularly in the month prior to study enrollment.
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 |
|---|---|---|
| NaltrexoneAlso: ReVianaltrexone (50 mg orally) for 12-week treatment period; 3 and 6 months post-treatment follow-up | Drug | 1 |
| placeboplacebo for 12-week treatment period; 3 and 6 months post-treatment follow-up | Drug | 2 |
Primary outcome
Drinking days and heavy drinking days
Time frame: 12-week trial; 3 and 6 months post-treatment follow-up
2 secondary outcomes
Alcohol-related problems
Time frame: 12-week trial; 3 and 6 months post-treatment follow-up
Biological measures of alcohol consumption (i.e., serum GGTP and CDT)
Time frame: 12-week trial; 3 and 6 months post-treatment follow-up
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 20 Jun 2011.
- Results publication: PubMed 19593174Kranzler HR, Tennen H, Armeli S, Chan G, Covault J, Arias A, Oncken C. Targeted naltrexone for problem drinkers. J Clin Psychopharmacol. 2009 Aug;29(4):350-7. doi: 10.1097/JCP.0b013e3181ac5213.
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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.
Henry R. Kranzler, MD 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 4 study testing Naltrexone in people with Alcoholism and Alcohol Drinking, run by UConn Health 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 20 Jun 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Drinking days and heavy drinking days (time frame: 12-week trial; 3 and 6 months post-treatment follow-up). 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 NCT00369408, 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 20 Jun 2011.