Alcohol use disorder can be improved without quitting through behavioural harm-reduction: Lancet
USA: Combined behavioural harm-reduction and pharmacological treatment can reduce alcohol use and alcohol-related harm without having to quit or abstain from alcohol, finds a recent study in the journal Lancet Psychiatry. The treatment given for 12-weeks to in people experiencing homelessness and alcohol use disorder also improved physical health-related quality of life.
The researchers also found not consistent but positive findings for behavioural harm-reduction treatment alone. Harm-reduction is a treatment that aims to incrementally reduce alcohol-related harm and improve health-related quality of life without requiring abstinence.
"In people experiencing homelessness and alcohol use disorder, the rate of alcohol-related mortality is high and calls for effective and accessible treatment. However, typical abstinence-based treatments does not engage this population," wrote the authors. "Recent studies have shown the effectiveness and acceptability of harm-reduction in this population. Harm-reduction is a treatment that aims to incrementally reduce alcohol-related harm and improve health-related quality of life without requiring abstinence."
Prof Susan E Collins, University of Washington School of Medicine, Seattle, WA, USA, and colleagues aimed to test the efficacy of combined pharmacological and behavioural harm-reduction treatment for alcohol use disorder (HaRT-A) in people experiencing homelessness and alcohol use disorder.
For the purpose, the researchers conducted a randomised clinical trial at three community-based service sites in Seattle, WA, USA. It included 308 adults (aged 21–65 years) who met the DSM-IV-TR criteria for alcohol use disorder and who experienced homelessness in the past year. They were randomly assigned in the ratio 1:1:1:1 to receive either HaRT-A plus intramuscular injections of 380 mg extended-release naltrexone (XR-NTX; HaRT-A plus XR-NTX group, n=74); HaRT-A plus placebo injection (HaRT-A plus placebo group, n=78); HaRT-A alone (HaRT-A alone group, n=79); or community-based supportive services as usual (services-as-usual control group, n=77).
Patients assigned to receive HaRT-A attended sessions at baseline (week 0) and in weeks 1, 4, 8, and 12. XR-NTX and placebo injections were administered in weeks 0, 4, and 8. All participants were invited to follow-up assessments at weeks 4, 8, 12, 24, and 36.
The primary outcomes were self-reported alcohol use quantity (ie, alcohol quantity consumed on peak drinking occasion, as measured with the Alcohol Quantity Use Assessment questionnaire) and frequency (measured with the Addiction Severity Index), alcohol-related harm (measured with the Short Inventory of Problems-2R questionnaire), and physical and mental health-related quality of life (measured with the Short Form-12 survey).
Using piecewise growth modelling and an intention-to-treat model, the researchers compared the effects of the three active treatment groups with the services-as-usual control group, and the HaRT-A plus XR-NTX group with the HaRT-A plus placebo group, over the 12-week treatment course and during the 24 weeks following treatment withdrawal.
Key findings of the study include:
- Compared with the services-as-usual control group, the HaRT-A plus XR-NTX group showed significant improvements from baseline to 12 weeks post-treatment across four of the five primary outcomes: peak alcohol quantity (linear B −0·48; full model Cohen's d=–0·68), alcohol frequency (linear B −4·42; full model Cohen's d=–0·16), alcohol-related harm (linear B −2·22; full model Cohen's d=–0·56), and physical health-related quality of life (linear B 0·66; full model Cohen's d=0·43).
- Compared with the services-as-usual control group, the HaRT-A plus placebo group showed significant improvements in three of the five primary outcomes: peak alcohol quantity (linear B −0·41; full model Cohen's d=–0·23), alcohol frequency (linear B −5·95; full model Cohen's d=–0·13), and physical health-related quality of life (linear B 0·53; full model Cohen's d=0·35).
- Compared with the services-as-usual control group, the HaRT-A alone group showed significant improvements in two of the five primary outcomes: alcohol-related harm (linear B −1·58; full model Cohen's d=–0·40) and physical health-related quality of life (linear B 0·63; full model Cohen's d=0·41).
- After treatment discontinuation at 12 weeks, the active treatment groups plateaued, whereas the services-as-usual group showed improvements. Thus, during the post-treatment period (weeks 12 to 36), the services-as-usual control group showed greater reductions in alcohol-related harm compared with both the HaRT-A plus XR-NTX group (linear B 0·96; full model Cohen's d=0·24) and the HaRT-A alone group (linear B 1·02; full model Cohen's d=0·26).
- During the post-treatment period, the services-as-usual control group significantly improved on mental health-related quality of life compared with the HaRT-A alone group (linear B −0·46; full model Cohen's d=–0·28), and on physical health-related quality of life compared with the HaRT-A plus XR-NTX group (linear B −0·42; full model Cohen's d=–0·27), the HaRT-A plus placebo group (linear B −0·42; full model Cohen's d=–0·27), and the HaRT-A alone group (linear B −0·47; full model Cohen's d=–0·31).
- For all other primary outcomes, there were no significant linear differences between the services-as-usual and active treatment groups.
- When comparing the HaRT-A plus placebo group with the HaRT-A plus XR-NTX group, there were no significant differences for any of the primary outcomes.
- Missing data analysis indicated that participants were more likely to drop out in the services-as-usual control group than in the active treatment groups; however, primary outcome findings were found to be robust to attrition.
- Participants in the HaRT-A plus XR-NTX, HaRT-A plus placebo, and HaRT-A alone groups were not more likely to experience adverse events than those in the services-as-usual control group.
"Considering the non-significant differences between participants receiving HaRT-A plus placebo and HaRT-A plus XR-NTX, the combined pharmacological and behavioural treatment effect cannot be attributed to XR-NTX alone," wrote the authors. "Future studies are needed to further investigate the relative contributions of the pharmacological and behavioural components of harm-reduction treatment for alcohol use disorder, and to ascertain whether a maintenance treatment approach could extend these positive outcome trajectories."
The study titled, "Combining behavioral harm-reduction treatment and extended-release naltrexone for people experiencing homelessness and alcohol use disorder in the USA: a randomised clinical trial," is published in the journal Lancet Psychiatry.
DOI: https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(20)30489-2/fulltext
