Addiction (Abingdon, England) · 2025
Secondary analysis of a combined harm-reduction treatment and extended-release naltrexone randomized clinical trial for alcohol use disorder: Differences across race, ethnicity and sex assigned at birth.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Goldstein Silvi C, Weiss Nicole H, Yang Manshu, Feldstein Ewing Sarah W, Collins Susan E
Аннотация
BACKGROUND AND AIMS: In a prior randomized clinical trial (RCT), combined pharmacobehavioral harm-reduction treatment improved alcohol outcomes and physical health-related quality of life (PH-QoL). In this secondary analysis, we tested race, ethnicity and sex assigned at birth as predictors and moderators of these effects.
DESIGN: Secondary study of a four-arm RCT.
SETTING: Community settings serving people experiencing homelessness in the US Pacific Northwest.
PARTICIPANTS: Adults aged 21-65 (N = 308) with alcohol use disorder (AUD) who experienced past-year homelessness.
INTERVENTION: In the parent RCT, participants were randomized to brief behavioral harm-reduction treatment for AUD + extended-release naltrexone (HaRT-A + XR-NTX); HaRT-A + placebo; HaRT-A alone, or services-as-usual control.
MEASUREMENT: We tested whether baseline outcomes, trial inclusion, data missingness, treatment adherence, side effects, and treatment effects on alcohol frequency, quantity, alcohol-related harm, urinary ethyl glucuronide, and PH-QoL differed by race, ethnicity, and sex assigned at birth.
FINDINGS: Race, ethnicity and sex assigned at birth were not associated with differential trial inclusion, missingness, treatment adherence or side effects with one exception: the Multiracial/other people of color (POC) group attended fewer HaRT-A sessions than the white group (odds ratio [OR] = 0.49, p = 0.03, 95% confidence interval [CI] [0.25, 0.95]). There were no statistically significant moderators of the behavioral HaRT-A effect; however, Multiracial/other POC race (B = -3.34, p = 0.03, 95% CI [-6.35, -0.34]) and sex assigned at birth (B = 2.43, p = 0.04, 95% CI [0.14, 4.73]) moderated the XR-NTX versus placebo effect on one variable: PH-QoL. Simple slope analysis indicated the Multiracial/other POC group who received placebo showed improvement on PH-QoL (dy/dx = 2.61, p = 0.003, 95% CI [0.91, 4.31]); the XR-NTX group did not (dy/dx = -0.22, p = 0.79, 95% CI [-1.90, 1.45]). Among XR-NTX recipients, the female group (dy/dx = 2.89, p < 0.001, 95% CI [1.53, 4.25]) showed faster improvement rates than the male group (dy/dx = 1.19, p = 0.02, 95% CI [0.23, 2.16]) on PH-QoL.
CONCLUSION: Race, ethnicity and sex assigned at birth were largely not associated with trial inclusion, data missingness, treatment adherence, side effects, or outcomes in a combined harm-reduction treatment and extended-release naltrexone randomised clinical trial for alcohol use disorder (AUD). Although Multiracial/other people of color (POC) participants attended fewer brief behavioral harm-reduction treatment for AUD sessions, they did not differ from white participants on alcohol and physical health-related quality of life outcomes. Among participants receiving extended-release naltrexone (XR-NTX), women showed greater improvement than men on physical health-related quality of life. Compared with white participants, Multiracial/other POC participants who received XR-NTX showed less improvement than those who received placebo. Given their post hoc nature and limited power, findings are hypothesis-generating. They suggest the equitable utility of behavioral harm-reduction treatment and the importance of assessing sociodemographic differences in AUD treatment response.
DESIGN: Secondary study of a four-arm RCT.
SETTING: Community settings serving people experiencing homelessness in the US Pacific Northwest.
PARTICIPANTS: Adults aged 21-65 (N = 308) with alcohol use disorder (AUD) who experienced past-year homelessness.
INTERVENTION: In the parent RCT, participants were randomized to brief behavioral harm-reduction treatment for AUD + extended-release naltrexone (HaRT-A + XR-NTX); HaRT-A + placebo; HaRT-A alone, or services-as-usual control.
MEASUREMENT: We tested whether baseline outcomes, trial inclusion, data missingness, treatment adherence, side effects, and treatment effects on alcohol frequency, quantity, alcohol-related harm, urinary ethyl glucuronide, and PH-QoL differed by race, ethnicity, and sex assigned at birth.
FINDINGS: Race, ethnicity and sex assigned at birth were not associated with differential trial inclusion, missingness, treatment adherence or side effects with one exception: the Multiracial/other people of color (POC) group attended fewer HaRT-A sessions than the white group (odds ratio [OR] = 0.49, p = 0.03, 95% confidence interval [CI] [0.25, 0.95]). There were no statistically significant moderators of the behavioral HaRT-A effect; however, Multiracial/other POC race (B = -3.34, p = 0.03, 95% CI [-6.35, -0.34]) and sex assigned at birth (B = 2.43, p = 0.04, 95% CI [0.14, 4.73]) moderated the XR-NTX versus placebo effect on one variable: PH-QoL. Simple slope analysis indicated the Multiracial/other POC group who received placebo showed improvement on PH-QoL (dy/dx = 2.61, p = 0.003, 95% CI [0.91, 4.31]); the XR-NTX group did not (dy/dx = -0.22, p = 0.79, 95% CI [-1.90, 1.45]). Among XR-NTX recipients, the female group (dy/dx = 2.89, p < 0.001, 95% CI [1.53, 4.25]) showed faster improvement rates than the male group (dy/dx = 1.19, p = 0.02, 95% CI [0.23, 2.16]) on PH-QoL.
CONCLUSION: Race, ethnicity and sex assigned at birth were largely not associated with trial inclusion, data missingness, treatment adherence, side effects, or outcomes in a combined harm-reduction treatment and extended-release naltrexone randomised clinical trial for alcohol use disorder (AUD). Although Multiracial/other people of color (POC) participants attended fewer brief behavioral harm-reduction treatment for AUD sessions, they did not differ from white participants on alcohol and physical health-related quality of life outcomes. Among participants receiving extended-release naltrexone (XR-NTX), women showed greater improvement than men on physical health-related quality of life. Compared with white participants, Multiracial/other POC participants who received XR-NTX showed less improvement than those who received placebo. Given their post hoc nature and limited power, findings are hypothesis-generating. They suggest the equitable utility of behavioral harm-reduction treatment and the importance of assessing sociodemographic differences in AUD treatment response.