Alcoholism Treatment: Naltrexone & Therapy Help

randomized-controlled-trial PMID: 16670409

Quick Summary: A large study found that combining the medication naltrexone with medical support helped people with alcohol dependence stay sober longer. Adding behavioral therapy also helped, but another medication, acamprosate, didn't seem to make a difference.

What The Research Found

This study looked at different ways to treat alcohol dependence. Researchers found:

Naltrexone works: People taking naltrexone with medical support stayed sober more days than those taking a placebo (a "dummy" pill).

Therapy helps, too: Adding behavioral therapy to medical support also improved outcomes.

Acamprosate didn't help: This medication didn't show a benefit compared to a placebo.

Study Details

Who was studied: 1,383 adults with alcohol dependence.

How long: 16 weeks of treatment, plus a year of follow-up.

What they took: Participants were divided into groups that received:

Naltrexone
Acamprosate
Placebo pills
Behavioral therapy
Combinations of the above

What This Means For You

If you're struggling with alcohol dependence:

Talk to your doctor: Naltrexone, along with medical support, may be a helpful treatment option.

Consider therapy: Behavioral therapy can be a valuable addition to your treatment plan.

Don't give up: Even if one treatment doesn't work, there are other options to explore.

Study Limitations

Specific group: The study focused on people who had recently stopped drinking, so the results might not apply to everyone.

Placebo effect: The study showed that even taking a placebo pill with medical support helped. This highlights the importance of a good relationship with your doctor.

Long-term results: The benefits of the treatments weren't as strong after a year.

Key Findings

The COMBINE study found that naltrexone (100 mg/d) combined with medical management increased percent days abstinent (PDA) from alcohol compared to placebo (80.6% vs. 75.1%, P = .009). A combined behavioral intervention (CBI) also improved outcomes when paired with medical management (79.2% PDA). However, acamprosate (3 g/d) showed no significant efficacy vs. placebo. Notably, placebo pills combined with medical management outperformed CBI alone (73.8% vs. 66.6% PDA, P < .001). Naltrexone reduced the risk of heavy drinking (hazard ratio 0.72, 97.5% CI 0.53–0.98, P = .02), particularly without CBI.

Study Design

This randomized controlled trial (RCT) enrolled 1,383 adults (median age 44) with DSM-IV alcohol dependence across 11 U.S. academic centers. Participants were recently abstinent and followed for 16 weeks of treatment plus 1 year post-treatment. Nine groups tested combinations of naltrexone, acamprosate, placebo, and CBI. Outcomes included PDA and time to first heavy drinking day.

Dosage & Administration

Naltrexone: 100 mg/day orally.
Acamprosate: 3 g/day orally (divided into 333 mg three times daily).
Placebo: Inert pills matched to active medications.
CBI: Weekly behavioral therapy sessions focused on adherence, coping skills, and abstinence. All interventions were delivered alongside standardized medical management (e.g., physician visits).

Results & Efficacy

Naltrexone: Improved PDA during treatment (80.6%) vs. placebo (75.1%) with a significant interaction between naltrexone and CBI (P = .009).
CBI: Effective only when combined with medical management (79.2% PDA) but inferior to placebo alone (73.8% vs. 66.6% without pills, P < .001).
Acamprosate: No difference in PDA or heavy drinking risk vs. placebo (all P > .05).
Long-term: Effects diminished at 1-year follow-up, with no significant between-group differences.

Limitations

Population: Participants were recently abstinent and motivated to quit, limiting generalizability to less engaged patients.
Placebo design: Placebo groups received medical management, which may have confounded results by amplifying the placebo effect.
CBI fidelity: Variability in therapy delivery across sites could affect reproducibility.
Acamprosate dosage: The fixed 3 g/day dose may not account for individual metabolic differences.
Self-report bias: Alcohol use outcomes relied on participant recall, though biomarkers were used for validation.

Clinical Relevance

For alcohol-dependent patients, naltrexone plus medical management (e.g., physician support) may enhance abstinence rates, particularly in primary care settings where specialty behavioral therapy is unavailable. CBI adds value only when combined with medical management, not as standalone treatment. Acamprosate’s lack of efficacy suggests it may not be a first-line option. The strong placebo effect underscores the importance of patient-provider interactions in treatment success. However, results caution against overestimating short-term benefits, as long-term outcomes were less durable. Clinicians should prioritize naltrexone and structured support for alcohol dependence.

Note: This study does not evaluate taurine; the focus is on pharmacotherapies (naltrexone, acamprosate) and behavioral interventions for alcohol dependence.