Naltrexone for Heavy Drinking in Young Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephanie O'Malley, Yale University
ClinicalTrials.gov Identifier:
NCT00568958
First received: December 4, 2007
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

In this study, 140 heavy drinking young adults (aged 18-25) will be provided with brief counseling and either naltrexone, a medication that is FDA-approved for the treatment of alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for administering low-dose naltrexone, in which daily dosing will be combined with targeted dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted naltrexone will result in greater reductions in frequency of heavy and any drinking compared with daily + targeted placebo.


Condition Intervention Phase
Alcohol Consumption
Alcoholic Intoxication
Alcoholism
Alcohol-induced Disorders
Behavioral: BASICS counseling
Drug: naltrexone
Drug: placebo naltrexone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Naltrexone for Heavy Drinking in Young Adults

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Frequency of heavy episodic drinking (5 or more drinks in a day for males, 4 or more drinks in a day for females) [ Time Frame: 8-week treatment period and through 12 months of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alternative measures of alcohol involvement including frequency of drinking to intoxication, frequency of drinking to an estimated BAC of .08 or higher and alcohol-related consequences [ Time Frame: 8-week treatment period and through 12 months of follow-up ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: February 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone
Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
Behavioral: 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:
  • brief counseling
  • brief intervention
Drug: naltrexone
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:
  • ReVia
  • Depade
Placebo Comparator: Placebo Naltrexone
Placebo Naltrexone (targeted + daily) + BASICS Counseling
Behavioral: 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:
  • brief counseling
  • brief intervention
Drug: placebo naltrexone
Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks.

Detailed Description:

NIAAA has designated underage drinking as a priority research area. Of note, the highest prevalence of problem alcohol use is among young adults ages 18-25. Heavy drinking that occurs during this period can have important immediate and lifelong adverse consequences. Behavioral interventions, notably BASICS (Brief Alcohol Screening and Intervention for College Students), have been developed to help young adults reduce their drinking. Although these interventions are effective, including with college students mandated to treatment and others with minimal motivation to stop drinking, the effect sizes are modest, suggesting that new approaches are needed to enhance these interventions. A promising strategy yet to be tested in young adults is the use of the opiate antagonist naltrexone. In other research, naltrexone has been shown to reduce the amount of alcohol consumed, even in the absence of strong internal motivation to change, and to reduce the frequency of any and heavy drinking in problem drinkers seeking treatment. Thus we propose to conduct an 8 week double-blind placebo-controlled trial to test the combined efficacy of BASICS + naltrexone in 132 young adults aged 18-25 who drink heavily. A novel strategy will be used for administering low-dose naltrexone, in which daily dosing will be combined with targeted dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted naltrexone will result in greater reductions in frequency of heavy and any drinking compared with daily + targeted placebo. In order to enhance the sensitivity with which we are able to assess naltrexone's effects on drinking, daily ratings will be obtained during treatment. These will permit us to examine alternative measures of alcohol involvement (e.g., reports of subjective intoxication, estimated blood alcohol levels) in addition to the traditional measures based on number of drinks consumed. These data will also be used to examine potential mediators (e.g., craving, subjective effects of alcohol) of treatment response in order to better understand the effects of naltrexone. The durability of treatment effects will be examined at 3, 6 and 12 months after randomization. Demonstration of the efficacy of naltrexone in this population will provide the essential information needed for its adoption by college counseling centers and other health care settings committed to reducing the risk of heavy drinking in young adults.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each subject must:

  1. Be between the ages of 18 and 25;
  2. 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;
  3. Be able to read English and show no evidence of significant cognitive impairment.
  4. 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:

  1. 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;
  2. 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;
  3. Have a current diagnosis of DSM-IV drug dependence other than nicotine, or a lifetime history of DSM-IV opiate dependence;
  4. 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.
  5. 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.
  6. Have a history of hypersensitivity to naltrexone;
  7. Be considered by the investigators to be an unsuitable candidate for receipt of an investigational drug.
  8. The investigators may exclude participants who complete daily questionnaires on less than half of the days between intake and treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568958

Locations
United States, Connecticut
Connecticut Mental Health Center - Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Stephanie O'Malley, PhD Yale University
  More Information

No publications provided

Responsible Party: Stephanie O'Malley, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00568958     History of Changes
Other Study ID Numbers: NIAAA_OMALLEY-AA016621, R01AA016621, NIH grant AA016621-01
Study First Received: December 4, 2007
Last Updated: August 7, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Yale University:
heavy episodic drinking
young adults
naltrexone
BASICS counseling
alcohol-related consequences
double-blind trial
randomized clinical trial

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholic Intoxication
Alcoholism
Alcohol-Induced Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 09, 2014