Naltrexone Treatment

Randomized clinical trial of naltrexone alone or with the addition of sertraline

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Persons diagnosed with alcohol dependence, both AI/ANs (n = 68) and non-AI/ANs (n = 33) received 16 weeks of either: 1) placebo, 2) naltrexone alone, or 3) naltrexone plus sertraline. Naltrexone, an FDA-approved medication for alcohol use disorder (AUD), reduces alcohol cravings and consumption by blocking the positive feelings and effects of alcohol use. Sertraline, an antidepressant selective serotonin reuptake inhibitor, has been used in addition to naltrexone therapy as a means to further suppress drinking in patients with AUD. Everyone received up to 9 sessions of medical management and support sessions provided by paraprofessionals collaborating with the medical practitioners who provided the medications.

Outcomes

Estimates of changes or differences in alcohol-related problems and the stability of those changes or differences. 

Medium/Mixed Level of Change

Naltrexone alone improved total abstinence and decreased relapse to heavy drinking. 

Outcomes were reported immediately after the end of intervention with no longer-term follow-up. Naltrexone alone was significantly better than placebo for total abstinence and somewhat longer time to first heavy drinking day in the total sample. There was no additional benefit to adding sertraline to naltrexone alone. While these results were generally the same for the AI/AN subsample, most improvements were not as strong, possibly due to a reduction in sample size. During treatment, the percentage of days abstinent from alcohol for AI/ANs was higher (8 vs. 4) and alcohol-related consequences were lower when compared to the placebo condition.

Costs

Two domains estimating start-up and ongoing expenses. 

Both start-up and ongoing costs high due to medical staffing and training for counselors. 

Start-up requires training of staff and supervision in medical management and support sessions, making estimated start-up costs high. Costs continued to be expensive because medical professionals are required for administering medication and conducting follow up.

Cultural Engagement

Two indicators of cultural and Tribal/community contributions. 

Focus groups with Tribes and community but unclear how employed. 

Focus groups composed of Tribal, community, and human service personnel were held to promote culturally sensitive procedures and assessments. It was not clear how this input was used.

Treatment took place at main study center and rural clinics. 

Participants were from 5 rural communities in Alaska; the research sessions initially took place at a non-rural “main study site” with remaining sessions held in the rural community. Participants were AI/AN (n = 68) and non-Native (n = 33) patients diagnosed with alcohol dependence, mostly male (66%), ranging in age from 18 to 65 years old.

Staffing Needs

Credentials and/or background of personnel who delivered the intervention. 

Advanced Degree (post BA) Professional, Certified Professional

Physicians, nurses, masters-level counselors, and paraprofessionals. 

Physicians to prescribe medication, nurses to provide initial doses, masters-level clinicians/counselors, and paraprofessionals to provide medication management and supportive counseling.

Research Design

Methods employed to gather research data. 

Randomized controlled experimental design

Developmental stage of research

Stage of development of the evidence supporting this intervention. 

Early Stage

Early stage of research to apply medication treatment to AI/AN populations. 

The finding that naltrexone alone was useful in treatment of alcohol dependence (similar to moderate to severe AUD) for Alaska Natives and non-Natives is promising. While we know that naltrexone is a well-established treatment in non-Native populations, more research with larger AI/AN sample sizes would be needed to clarify acceptability, feasibility, and efficacy.

Potential

Narrative offered by expert reviewers providing overall comments or evaluations about the intervention. 

Could be useful in rural settings where there is consultation with trained medical practitioners. 

This study shows early evidence that naltrexone alone can be used to treat alcohol dependence (similar to moderate to severe AUD) in rural Alaskan Natives and non-Natives. This demonstrates the potential for using paraprofessionals, working in collaboration with medically certified professionals, to provide medical management and supportive counseling in rural settings.

References

Primary 

O’Malley SS, Robin RW, Levenson AL, et al. Naltrexone alone and with sertraline for the treatment of alcohol dependence in Alaska Natives and non-Natives residing in rural settings: A randomized controlled trial. Alcohol Clin Exp Res. 2008;32(7):1271-1283. https://pubmed.ncbi.nlm.nih.gov/1 

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