AlcoholismPhase 4NCT00000448
Naltrexone Treatment for Alcoholic Women
A Phase 4 study testing naltrexone in people with Alcoholism and Eating Disorder, run by Yale University at 1 site in United States.
Trial summary
This study will assess naltrexone's effectiveness in treating alcoholism in women and provide information on its potential value in treating eating disorders common among alcoholic women. Alcoholic women with and without both eating disorders and depression will be randomly assigned to placebo or naltrexone treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Alcoholism, Eating Disorder
- What is being tested?
- naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1995to Dec 2000
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Meets criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days.
- Able to read English and complete study evaluations.
- A stable residence and a telephone to ensure that subjects can be located during the study.
Who cannot join
- Meets criteria for dependence on another psychoactive substance besides alcohol or nicotine.
- Regular use of psychoactive drugs except antidepressants.
- Current use of disulfiram (Antabuse).
- Psychotic or otherwise severely psychiatrically disabled.
- Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac pathology.
- Abstinent longer than 30 days prior to admission to program.
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- Hepatocellular disease or elevated bilirubin levels.
- Individuals with present history of opiate abuse or who require the use of opioid analgesics.
- Women who are pregnant, nursing, or not using a reliable method of birth control.
- Women who are significantly overweight or significantly underweight.
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Abuse Treatment Unit, Yale University
New Haven, Connecticut, 06511
About this study
Official title: Naltrexone: Consummatory Behaviors in Alcoholic Women
This study will assess naltrexone's effectiveness in treating alcoholism in women and provide information on its potential value in treating eating disorders common among alcoholic women. Alcoholic women with and without both eating disorders and depression will be randomly assigned to placebo or naltrexone treatment. Each group will receive behavioral therapy for 12 weeks, with followup 6 months after treatment.
Read the detailed description
Background: Despite important gender differences in drinking patterns, physiological effects of alcohol, and co-occurring psychiatric conditions, relatively little is known about the efficacy of naltrexone for the treatment of alcohol dependence in women. This study investigated the safety and efficacy of naltrexone in combination with Cognitive Behavioral Coping Skills Therapy (CBCST) in a sample of alcohol-dependent women, some with comorbid eating pathology.
Methods: One hundred three women meeting DSM-IV criteria for alcohol dependence (29 with comorbid eating disturbances) were randomized to receive either naltrexone or placebo for 12 weeks in addition to weekly group CBCST.
- Conditions
- Alcoholism, Eating Disorder
- Being tested
- naltrexone, Placebo
- Medical subject headings
- Alcoholism, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexoneDrug
Also called Revia, Depade
Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.
PlaceboDrug
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects were given an inert placebo for 2 days, followed by daily doses of matching placebo for a total of 12 weeks. Receives: Drug: Placebo |
| Naltrexone | Experimental | Subjects were prescribed 25 mg naltrexone for 2 days, followed by daily doses of 50 mg of naltrexone for a total of 12 weeks. Receives: Drug: naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first day of drinking
Measured: 12 week treatment period
Time to first day of heavy drinking
Defined as consuming 4 or more drinks during the 12-week period
Measured: 12 weeks
Secondary outcomes (5)
Percentage of days abstinent
Measured: 12 weeks of treatment
Percentage of heavy drinking days
Measured: 12 weeks of treatment
Beck Depression Index
The Beck Depression Inventory (BDI, BDI-1A, BDI-II), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory. Higher total scores indicate more severe depressive symptoms. This was administered bi-weekly throughout the treatment period.
Measured: 12 weeks of treatment
Obsessive Compulsive Drinking Scale (OCDS)
The OCDS was developed to reflect obsessionality and compulsivity related to craving and drinking behavior.
Measured: Baseline, Month 1, 2, 3
Eating Disorder Examination (EDE)
The Eating Disorder Examination Interview (EDE) devised by Cooper \& Fairburn (1987) is a semi-structured interview conducted by a clinician in the assessment of an eating disorder. The questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28 day period. The test is scored on a 7 point scale from 0-6. With a zero score indicating not having engaged in the questioned behavior.
Measured: baseline, month 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startOct 1995
- Primary completionDec 2000
- Study completionDec 2000
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.
- More trials run by Yale UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Stephanie S O'Malley, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000448
- Sponsor's protocol ID
- NIAAAOMA10225
- Other IDs
- R01AA010225
- Status last verified
- May 2014
- First submitted
- 2 Nov 1999
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Malley SS, Sinha R, Grilo CM, Capone C, Farren CK, McKee SA, Rounsaville BJ, Wu R. Naltrexone and cognitive behavioral coping skills therapy for the treatment of alcohol drinking and eating disorder features in alcohol-dependent women: a randomized controlled trial. Alcohol Clin Exp Res. 2007 Apr;31(4):625-34. doi: 10.1111/j.1530-0277.2007.00347.x.
PubMed 17374042
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone: Consummatory Behaviors in Alcoholic Women
- ClinicalTrials.gov ID
- NCT00000448
- Acronym / sponsor ID
- NIAAAOMA10225
- Conditions
- Alcoholism, Eating Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 1995
- Primary completion
- Dec 2000 (actual)
- Study completion
- Dec 2000 (actual)
- First posted
- 3 Nov 1999 (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.
This study will assess naltrexone's effectiveness in treating alcoholism in women and provide information on its potential value in treating eating disorders common among alcoholic women. Alcoholic women with and without both eating disorders and depression will be randomly assigned to placebo or naltrexone treatment. Each group will receive behavioral therapy for 12 weeks, with followup 6 months after treatment.
Detailed description
Background: Despite important gender differences in drinking patterns, physiological effects of alcohol, and co-occurring psychiatric conditions, relatively little is known about the efficacy of naltrexone for the treatment of alcohol dependence in women. This study investigated the safety and efficacy of naltrexone in combination with Cognitive Behavioral Coping Skills Therapy (CBCST) in a sample of alcohol-dependent women, some with comorbid eating pathology.
Methods: One hundred three women meeting DSM-IV criteria for alcohol dependence (29 with comorbid eating disturbances) were randomized to receive either naltrexone or placebo for 12 weeks in addition to weekly group CBCST.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects were given an inert placebo for 2 days, followed by daily doses of matching placebo for a total of 12 weeks. |
| Naltrexone | Experimental | Drug: naltrexoneSubjects were prescribed 25 mg naltrexone for 2 days, followed by daily doses of 50 mg of naltrexone for a total of 12 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meets criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days.
- Able to read English and complete study evaluations.
- A stable residence and a telephone to ensure that subjects can be located during the study.
Key exclusion criteria (10 listed)
- Meets criteria for dependence on another psychoactive substance besides alcohol or nicotine.
- Regular use of psychoactive drugs except antidepressants.
- Current use of disulfiram (Antabuse).
- Psychotic or otherwise severely psychiatrically disabled.
- Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac pathology.
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: Revia, DepadeNaltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence. | Drug | Naltrexone |
| PlaceboA placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. | Drug | Placebo |
Primary outcome
Time to first day of drinking
Time frame: 12 week treatment period
Time to first day of heavy drinking
Time frame: 12 weeks
Defined as consuming 4 or more drinks during the 12-week period
5 secondary outcomes
Percentage of days abstinent
Time frame: 12 weeks of treatment
Percentage of heavy drinking days
Time frame: 12 weeks of treatment
Beck Depression Index
Time frame: 12 weeks of treatment
Obsessive Compulsive Drinking Scale (OCDS)
Time frame: Baseline, Month 1, 2, 3
Eating Disorder Examination (EDE)
Time frame: baseline, month 1, 2, 3
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 7 May 2014.
- Results publication: PubMed 17374042O'Malley SS, Sinha R, Grilo CM, Capone C, Farren CK, McKee SA, Rounsaville BJ, Wu R. Naltrexone and cognitive behavioral coping skills therapy for the treatment of alcohol drinking and eating disorder features in alcohol-dependent women: a randomized controlled trial. Alcohol Clin Exp Res. 2007 Apr;31(4):625-34. doi: 10.1111/j.1530-0277.2007.00347.x.
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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.
Stephanie S O'Malley, PhD principal investigator
Yale University
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 Eating Disorder, run by Yale University 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 3 inclusion and 10 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 7 May 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 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?
Time to first day of drinking (time frame: 12 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?
On the ClinicalTrials.gov record for NCT00000448, 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 7 May 2014.