- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00568958
Naltrexone for Heavy Drinking in Young Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Connecticut Mental Health Center - Substance Abuse Treatment Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Each subject must:
- Be between the ages of 18 and 25;
- Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on an occasion;
- Be able to read English and show no evidence of significant cognitive impairment.
- That women of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, or tubal ligation), be nonlactating, practicing a reliable method of birth control, and have a negative urine pregnancy test prior to initiation of treatment.
Exclusion Criteria:
No subject may:
- Exhibit current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including AST or ALT levels greater than 3 times normal or bilirubin levels greater than 110% of normal. Individuals with common medical conditions (e.g., asthma, diabetes mellitus, thyroid disease) that are adequately controlled and who have a relationship with a primary-care practitioner will not be excluded;
- Exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders, or substantial suicide or violence risk) by history or psychological examination;
- Have a current diagnosis of DSM-IV drug dependence other than nicotine, or a lifetime history of DSM-IV opiate dependence;
- Have a current DSM-IV diagnosis of alcohol dependence that is clinically severe defined by a) a history of seizures, delirium, or hallucinations during alcohol withdrawal, b) a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of > 8, c) report drinking to avoid withdrawal symptoms, or d) have had prior treatment of withdrawal.
- Have used opioids or concomitant therapy with any psychotropic drug in the past month, except that subjects who are on a stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months for the indications of Major Depressive Disorder, Premenstrual Syndrome (PMS), or Premenstrual Dysphoric Disorder (PMDD) will not be excluded; SSRIs are allowed due to their safety profile relative to other classes of antidepressants.
- Have a history of hypersensitivity to naltrexone;
- Be considered by the investigators to be an unsuitable candidate for receipt of an investigational drug.
- The investigators may exclude participants who complete daily questionnaires on less than half of the days between intake and treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Naltrexone
Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
|
Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates.
It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
Other Names:
Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks.
Other Names:
|
Placebo Comparator: Placebo Naltrexone
Placebo Naltrexone (targeted + daily) + BASICS Counseling
|
Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates.
It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
Other Names:
Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Heavy Episodic Drinking
Time Frame: Baseline
|
Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.
Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females.
A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor).
Baseline measures captured the prior 4 weeks.
|
Baseline
|
Frequency of Heavy Episodic Drinking
Time Frame: eight weeks
|
Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females over an eight week period. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor). |
eight weeks
|
Percent Days Abstinent From Drinking
Time Frame: Baseline
|
Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.
Baseline measures captured the prior 4 weeks.
|
Baseline
|
Percent Days Abstinent From Drinking
Time Frame: 8 Weeks
|
Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.
|
8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Drinks Per Drinking Day
Time Frame: Baseline
|
Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.
Baseline measures captured the prior 4 weeks.
|
Baseline
|
Number of Drinks Per Drinking Day
Time Frame: 8 Weeks
|
Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.
|
8 Weeks
|
Percentage of Drinking to an Estimated Blood Alcohol Concentration (BAC) of .08 or Higher
Time Frame: 8 weeks
|
Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. BAL (Blood Alcohol Level) was estimated using data from the daily diaries based on the number of drinks consumed, the duration of drinking, and total body water (based on gender, age, height and weight) using Curtin's formula. |
8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcohol Drinking
- Alcoholism
- Alcohol-Induced Disorders
- Alcoholic Intoxication
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Alcohol Deterrents
- Naltrexone
Other Study ID Numbers
- 0706002743
- R01AA016621 (U.S. NIH Grant/Contract)
- NIH grant AA016621-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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