Naltrexone for Heavy Drinking in Young Adults

NCT00568958 | Completed Phase 4 Results DMC

• 3 other identifiers: 0706002743R01AA016621NIH grant AA016621-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Consumption; Alcoholic Intoxication; Alcoholism; Alcohol-induced Disorders

Keywords

heavy episodic drinking; young adults; naltrexone; BASICS counseling; alcohol-related consequences; double-blind trial; randomized clinical trial

Outcome Measures

Primary Outcomes (4)

• Frequency of Heavy Episodic Drinking

  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

  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

  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

  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 Outcomes (3)

• Number of Drinks Per Drinking Day

  Baseline

• Number of Drinks Per Drinking Day

  8 Weeks

• Percentage of Drinking to an Estimated Blood Alcohol Concentration (BAC) of .08 or Higher

  8 weeks

Study Arms (2)

Naltrexone

EXPERIMENTAL

Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling

Behavioral: BASICS counseling; Drug: naltrexone

Placebo Naltrexone

PLACEBO COMPARATOR

Placebo Naltrexone (targeted + daily) + BASICS Counseling

Behavioral: BASICS counseling; Drug: placebo naltrexone

Interventions

BASICS counseling BEHAVIORAL

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.

Also known as: brief counseling, brief intervention

Naltrexone; Placebo Naltrexone

naltrexone DRUG

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.

Also known as: ReVia, Depade

Naltrexone

placebo naltrexone DRUG

Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks.

Placebo Naltrexone

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Connecticut Mental Health Center - Substance Abuse Treatment Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• O'Malley SS, Corbin WR, Leeman RF, DeMartini KS, Fucito LM, Ikomi J, Romano DM, Wu R, Toll BA, Sher KJ, Gueorguieva R, Kranzler HR. Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety. J Clin Psychiatry. 2015 Feb;76(2):e207-13. doi: 10.4088/JCP.13m08934.

  PMID: 25742208 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Alcoholic Intoxication; Alcoholism; Alcohol-Induced Disorders

Interventions

Crisis Intervention; Naltrexone

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Stephanie S. O'Malley
• Organization: Yale University School of Medicine

stephanie.omalley@yale.edu

203-974-7590

Study Officials

• Stephanie O'Malley, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 6, 2007
• Study Start: February 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 30, 2020
• Results First Posted: August 11, 2014

Record last verified: 2018-08

Locations

US (1)