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Clinical Trial
. 2020 Oct 1:215:108221.
doi: 10.1016/j.drugalcdep.2020.108221. Epub 2020 Aug 5.

Health-related quality of life and opioid use disorder pharmacotherapy: A secondary analysis of a clinical trial

Ali Jalali  1 , Danielle A Ryan  2 , Philip J Jeng  2 , Kathryn E McCollister  3 , Jared A Leff  2 , Joshua D Lee  4 , Edward V Nunes  5 , Patricia Novo  4 , John Rotrosen  4 , Bruce R Schackman  2 , Sean M Murphy  2
Affiliations
Clinical Trial

Health-related quality of life and opioid use disorder pharmacotherapy: A secondary analysis of a clinical trial

Ali Jalali et al. Drug Alcohol Depend. .

Abstract

Objective: To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients.

Methods: We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes.

Results: We identified two subpopulations: HRQoL "pharmacotherapy responsive" (82.3 %) and HRQoL "characteristic sensitive" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics.

Conclusion: Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.

Keywords: Health-related quality-of-life; Latent class analysis; Medications for opioid use disorder; Opioid use disorder; Regression mixture modeling.

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Conflict of interest statement

Declarations of interest

Dr. Murphy reports having consulted for Sandoz Inc. for work unrelated to the investigation reported here. Ms. Novo reports grants from NIDA during the conduct of the study and outside the submitted work. Dr. Rotrosen reports grants from NIDA/NIH, medication for the present study from Indivior, and medication and/or funds for other studies (as principal investigator or investigator) from Indivior and Alkermes; he serves as a non-paid member of an Alkermes study steering committee. Authors not named here have disclosed no conflicts of interest.

Figures

Figure 1.
Figure 1.
Mean HRQoL Overall and by Treatment Arm Stratified by Successful Initiation HRQoL = Health Related Quality-of-life XR-NTX = Extended-Release Naltrexone BUP-NX = Buprenorphine-Naloxone Notes: The plot shows unadjusted means of HRQoL at baseline and over the study period for those participants that successfully initiated treatment (per protocol N=474) and also stratified by pharmacotherapy randomization (XR-NTX, N=204; BUP-NX, N=270). Dashed lines indicate the 25th and 75th percentiles. Sample sizes for each observation period are reported in Table S4 in the supplemental appendix.
Figure 2.
Figure 2.
Adjusted Baseline HRQoL and Predicted Means Over Time by Latent Class HRQoL = Health Related Quality-of-life Notes: Initial HRQoL was adjusted for baseline variables based on class assignment in month 1. Predicted means of HRQoL in months 1–7, and 9 are derived from the statistical model using the method of recycled predictions.
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