 |
|
Efficacy and Tolerability of Long-Acting Injectable Naltrexone for Alcohol Dependence
A Randomized Controlled Trial
James C. Garbutt, MD;
Henry R. Kranzler, MD;
Stephanie S. O’Malley, PhD;
David R. Gastfriend, MD;
Helen M. Pettinati, PhD;
Bernard L. Silverman, MD;
John W. Loewy, PhD;
Elliot W. Ehrich, MD; for the Vivitrex Study Group
JAMA. 2005;293:1617-1625.
Context Alcohol dependence is a common disorder associated with significant morbidity and mortality. Naltrexone, an opioid antagonist, has been shown to be effective for treatment of alcohol dependence. However, adherence to daily oral pharmacotherapy can be problematic, and clinical acceptance and utility of oral naltrexone have been limited.
Objective To determine efficacy and tolerability of a long-acting intramuscular formulation of naltrexone for treatment of alcohol-dependent patients.
Design, Setting, and Participants A 6-month, randomized, double-blind, placebo-controlled trial conducted between February 2002 and September 2003 at 24 US public hospitals, private and Veterans Administration clinics, and tertiary care medical centers. Of the 899 individuals screened, 627 who were diagnosed as being actively drinking alcohol-dependent adults were randomized to receive treatment and 624 received at least 1 injection.
Intervention An intramuscular injection of 380 mg of long-acting naltrexone (n = 205) or 190 mg of long-acting naltrexone (n = 210) or a matching volume of placebo (n = 209) each administered monthly and combined with 12 sessions of low-intensity psychosocial intervention.
Main Outcome Measure The event rate of heavy drinking days in the intent-to-treat population.
Results Compared with placebo, 380 mg of long-acting naltrexone resulted in a 25% decrease in the event rate of heavy drinking days (P = .03) and 190 mg of naltrexone resulted in a 17% decrease (P = .07). Sex and pretreatment abstinence each showed significant interaction with the medication group on treatment outcome, with men and those with lead-in abstinence both exhibiting greater treatment effects. Discontinuation due to adverse events occurred in 14.1% in the 380-mg and 6.7% in the 190-mg group and 6.7% in the placebo group. Overall, rate and time to treatment discontinuation were similar among treatment groups.
Conclusions Long-acting naltrexone was well tolerated and resulted in reductions in heavy drinking among treatment-seeking alcohol-dependent patients during 6 months of therapy. These data indicate that long-acting naltrexone can be of benefit in the treatment of alcohol dependence.
Author Affiliations: Department of Psychiatry, University of North Carolina School of Medicine, Chapel Hill (Dr Garbutt), Department of Psychiatry, University of Connecticut School of Medicine, Farmington (Dr Kranzler), Department of Psychiatry, Yale University School of Medicine, New Haven, Conn (Dr O’Malley), Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston (Dr Gastfriend), Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia (Dr Pettinati), Alkermes Inc, Cambridge, Mass (Drs Silverman, Loewy, and Ehrich). Dr Gastfriend is now with Alkermes Inc.
 CiteULike  Connotea  Del.icio.us  Digg  Reddit  Technorati  Twitter
What's this?
RELATED LETTERS
Naltrexone Treatment for Alcohol Dependency
Olivier Ameisen
JAMA. 2005;294(8):899-900.
EXTRACT
| FULL TEXT
Naltrexone Treatment for Alcohol Dependency—Reply
James C. Garbutt, Henry R. Kranzler, Stephanie S. O’Malley, David R. Gastfriend, Bernard L. Silverman, John W. Loewy, Elliot W. Ehrich, and Helen M. Pettinati
JAMA. 2005;294(8):900.
EXTRACT
| FULL TEXT
RELATED ARTICLE
Alcohol Abuse and Alcoholism
Sarah Ringold, Tiffany J. Glass, and Richard M. Glass
JAMA. 2005;293(13):1694.
EXTRACT
| FULL TEXT
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Improving Clinical Outcomes in Treating Heroin Dependence: Randomized, Controlled Trial of Oral or Implant Naltrexone
Hulse et al.
Arch Gen Psychiatry 2009;66:1108-1115.
ABSTRACT
| FULL TEXT
Naltrexone implants after in-patient treatment for opioid dependence: randomised controlled trial
Kunoe et al.
Br. J. Psychiatry 2009;194:541-546.
ABSTRACT
| FULL TEXT
Sweet Liking Phenotype, Alcohol Craving and Response to Naltrexone Treatment in Alcohol Dependence
Garbutt et al.
Alcohol Alcohol 2009;44:293-300.
ABSTRACT
| FULL TEXT
Naltrexone for the Management of Alcohol Dependence
Anton
NEJM 2008;359:715-721.
FULL TEXT
A 50-Year-Old Woman Addicted to Heroin: Review of Treatment of Heroin Addiction
O'Brien
JAMA 2008;300:314-321.
ABSTRACT
| FULL TEXT
Topiramate as Treatment for Alcohol Dependence--Reply
Johnson et al.
JAMA 2008;299:406-407.
FULL TEXT
Medications to Treat Alcohol Dependence: Adding to the Continuum of Care
Willenbring
JAMA 2007;298:1691-1692.
FULL TEXT
Prevalence, Correlates, Disability, and Comorbidity of DSM-IV Alcohol Abuse and Dependence in the United States: Results From the National Epidemiologic Survey on Alcohol and Related Conditions
Hasin et al.
Arch Gen Psychiatry 2007;64:830-842.
ABSTRACT
| FULL TEXT
Association of a Functional Polymorphism in the {micro}-Opioid Receptor Gene With Alcohol Response and Consumption in Male Rhesus Macaques
Barr et al.
Arch Gen Psychiatry 2007;64:369-376.
ABSTRACT
| FULL TEXT
SUPPRESSION OF SYMPTOMS OF ALCOHOL DEPENDENCE AND CRAVING USING HIGH-DOSE BACLOFEN
BUCKNAM
Alcohol Alcohol 2007;42:158-160.
ABSTRACT
| FULL TEXT
Emerging approaches to managing alcohol dependence
SWIFT
Am J Health Syst Pharm 2007;64:S12-S22.
ABSTRACT
| FULL TEXT
Improving adherence in patients with alcohol dependence: A new role for pharmacists
Peterson
Am J Health Syst Pharm 2007;64:S23-S29.
ABSTRACT
| FULL TEXT
Clinical Advances in Pharmacological and Integrated Treatment Approaches for Alcohol and Drug Use Disorders
Dermatis and Galanter
Focus 2007;5:141-150.
ABSTRACT
| FULL TEXT
Preclinical Development and Clinical Implementation of Treatments for Substance Abuse Disorders
Pechnick et al.
Focus 2007;5:151-162.
ABSTRACT
| FULL TEXT
Guideline Watch (April 2007): Practice Guideline for the Treatment of Patients With Substance Use Disorders, 2nd Edition
Connery and Kleber
Focus 2007;5:163-166.
ABSTRACT
| FULL TEXT
Bibliography for Substance Abuse: Diagnosis and Treatment
Focus 2007;5:184-186.
FULL TEXT
Addicted Anesthesiology Residents: Recommendations After Treatment
Collins and McAllister
Anesth. Analg. 2006;103:515-515.
FULL TEXT
Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial.
Anton et al.
JAMA 2006;295:2003-2017.
ABSTRACT
| FULL TEXT
Injectable, Sustained-Release Naltrexone for the Treatment of Opioid Dependence: A Randomized, Placebo-Controlled Trial
Comer et al.
Arch Gen Psychiatry 2006;63:210-218.
ABSTRACT
| FULL TEXT
Long acting injectable naltrexone is effective and safe for treating alcohol dependence
Killeen
Evid. Based Ment. Health 2005;8:100-100.
FULL TEXT
Pharmacokinetics of Long-Acting Naltrexone in Subjects With Mild to Moderate Hepatic Impairment
Turncliff et al.
J Clin Pharmacol 2005;45:1259-1267.
ABSTRACT
| FULL TEXT
Naltrexone Treatment for Alcohol Dependency
Ameisen
JAMA 2005;294:899-900.
FULL TEXT
Anticraving Medications for Relapse Prevention: A Possible New Class of Psychoactive Medications
O'Brien
Am. J. Psychiatry 2005;162:1423-1431.
ABSTRACT
| FULL TEXT
Physician Substance Abuse--Reply
Gastfriend
JAMA 2005;294:427-427.
FULL TEXT
Monthly Injectable Naltrexone Is Efficacious for Alcohol Dependence
JWatch Psychiatry 2005;2005:10-10.
FULL TEXT
Intramuscular Naltrexone Is Effective Against Alcoholism
JWatch Emergency Med. 2005;2005:3-3.
FULL TEXT
Monthly Injectable Naltrexone Is Efficacious for Alcohol Dependence
JWatch General 2005;2005:4-4.
FULL TEXT
Short cuts: What's new in the other general journals
Tonks
BMJ 2005;330:867-868.
FULL TEXT
|
