Evidence map›Paper›PMID 19053979›Full record

Trial reportAlcoholism, clinical and experimental research2009

Effect of extended-release naltrexone (XR-NTX) on quality of life in alcohol-dependent patients.

Helen M Pettinati, David R Gastfriend, Qunming Dong, Henry R Kranzler, Stephanie S O'Malley

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Alcoholism, clinical and experimental research, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01218958 (A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Medisorb® Naltrexone in Alcohol-Dependent Adults), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01218958 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Medisorb® Naltrexone in Alcohol-Dependent Adults

TypeinterventionalSponsorAlkermes, Inc.Ran2002 to 2003Enrolled624ConditionsAlcoholismArmsMedisorb naltrexone 190 mg, Medisorb naltrexone 380 mg, Placebo matching Medisorb naltrexone 190 mg, Placebo matching Medisorb naltrexone 380 mg
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Quality of life measures in treatment for active substance misuse: a scoping review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Article
  5. Hazardous drinking and alcohol use disorders.Nature reviews. Disease primers · 2022
    Review
  6. Article
  7. Review
  8. Naltrexone: Not Just for Opioids Anymore.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2016
    Review
  9. The opioid receptors as targets for drug abuse medication.British journal of pharmacology · 2015
    Review
  10. Using the SF-6D to measure the impact of alcohol dependence on health-related quality of life.The European journal of health economics : HEPAC : health economics in prevention and care · 2015
    Article
  11. Functional alterations in the dorsal raphe nucleus following acute and chronic ethanol exposure.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2015
    Article
  12. Article
  13. Alcoholism risk reduction in France: a modernised approach related to alcohol misuse disorders.International journal of environmental research and public health · 2014
    Article
  14. Therapy for alcoholic liver disease.World journal of gastroenterology · 2014
    Review
  15. Review
  16. Article
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Helen M PettinatiDepartment of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA. Pettinati_H@mail.trc.upenn.edu
David R Gastfriend
Qunming Dong
Henry R Kranzler
Stephanie S O'Malley
Alkermes (United States) · USUConn Health · USUniversity of Pennsylvania · US

Funding

BEHAVIORAL SUPPORT WITH PHARMACOTHERAPY FOR ALCOHOLICSU10AA011768 · NIAAA · UNIVERSITY OF PENNSYLVANIA · PI PETTINATI, HELEN M · 1997 to 2004
$2.1M
NIAAA NIH HHS U10 AA011768
6 · The paper itself

Abstract

backgroundExtended-release naltrexone (XR-NTX) is a once-a-month injectable formulation for the treatment of alcohol dependence previously shown to reduce drinking and heavy drinking relative to placebo (Garbutt et al., 2005). A 24-week, randomized, double-blind, placebo-controlled study established the efficacy and safety of XR-NTX in this patient population. In this report, the effect of XR-NTX on quality of life (QOL) was examined.

methodsAlcohol-dependent patients were randomly assigned to receive XR-NTX 380 mg (N = 205), XR-NTX 190 mg (N = 210), or placebo (N = 209), combined with a standardized psychosocial intervention. QOL was assessed using the Medical Outcomes Study 36-item short-form health survey, administered at baseline and at 4-week intervals during 24 weeks of treatment.

resultsCompared with U.S. population norms, patients showed initial impairment in the health-related QOL domains of mental health, social functioning, and problems with work or other daily activities due to emotional problems. Adherence to all 6 injections was 65% for XR-NTX 190 mg, 63% for XR-NTX 380 mg, and 64% for placebo. Generalized estimating equations analyses using an intention-to-treat sample revealed that XR-NTX 380 mg was associated with significantly greater improvements from baseline in mental health (p = 0.0496), social functioning (p = 0.010), general health (p = 0.048), and physical functioning (p = 0.028), compared with placebo. Linear regression analyses revealed that reductions from baseline in drinking (percentage of drinking days and percentage of heavy drinking days in the last 30 days) were significantly (p < 0.05) correlated with improvements in quality of life.

conclusionExtended-release naltrexone 380 mg in combination with psychosocial intervention was associated with improvements in QOL, specifically in the domains of mental health, social functioning, general health, and physical functioning.

Indexed as

AdultAlcohol DrinkingAlcoholismDelayed-Action PreparationsEmploymentEthnicityFemaleHealth StatusHumansMaleMental HealthMiddle AgedNaltrexoneNarcotic AntagonistsPsychiatric Status Rating ScalesQuality of LifeDelayed-Action PreparationsNaltrexoneNarcotic Antagonists

Identifiers

PMID19053979
PMCPMC2976586
OpenAlexW2011589251

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.