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Men's and women's response to treatment and perceptions of outcomes in a randomized controlled trial of injectable opioid assisted treatment for severe opioid use disorder.

ABSTRACT: To test whether there are gender differences in treatment outcomes among patients receiving injectable opioids for the treatment of long-term opioid-dependence. The study additionally explores whether men and women have different perceptions of treatment effectiveness.This study is a secondary analysis from SALOME, a double-blind, phase III, randomized controlled trial testing the non-inferiorirty of injectable hydromorphone to injectable diacetylmorphine among 202 long-term street opioid injectors in Vancouver (Canada). Given this was a secondary analysis, no a priori power calaculation was conducted. Differences in baseline characteristics and six-month treatment outcomes (illicit heroin use, opioid use, crack cocaine use, non-legal activities, physical and psychological health scores, urine positive for street heroin markers, and retention) were analysed by gender using fitted models. Responses to an open ended question on reasons for treatment effectiveness were explored with a thematic analysis.Men and women differed significantly on a number of characteristics at baseline. For example, women were significantly younger, presented to treatment with significantly higher rates of prior month sex work (31.5% vs. 0%), and used significantly more crack cocaine (14.71 vs. 8.38 days). After six-months of treatment there were no significant differences in treatment outcomes by gender, after adjusting for baseline values. For both men and women, improved health and quality of life were the most common reasons provided for treatment effectiveness, however women were more specific in the types of health improvements.Despite presenting to treatment with vulnerabilities not faced to the same extent by men, at six-months women did not differ significantly from men in tested trial efficacy outcomes. While the primary outcome in the trial was the reduction of illicit opioid use, in the open-ended responses both men and women focused their comments on improvement in health and quality of life as reasons for treatment effectiveness. The supervised model of care with injectable medications provides a particularly suitable framework for providing care to opioid-dependent men and women not attracted or retained by other treatments. The absence of statistical differences reported in this secondary analysis may be due to lack of adequate statistical power to detect meaningful effects.This trial is registered with ClinicalTrials.gov (NCT01447212) Registered: October 4, 2011 at the following link: https://clinicaltrials.gov/ct2/show/NCT01447212 .

SUBMITTER: Palis H

PROVIDER: S-EPMC5437624 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Men's and women's response to treatment and perceptions of outcomes in a randomized controlled trial of injectable opioid assisted treatment for severe opioid use disorder.

Palis Heather H Marchand Kirsten K Guh Daphne D Brissette Suzanne S Lock Kurt K MacDonald Scott S Harrison Scott S Anis Aslam H AH Krausz Michael M Marsh David C DC Schechter Martin T MT Oviedo-Joekes Eugenia E

Substance abuse treatment, prevention, and policy 20170519 1

<h4>Background</h4>To test whether there are gender differences in treatment outcomes among patients receiving injectable opioids for the treatment of long-term opioid-dependence. The study additionally explores whether men and women have different perceptions of treatment effectiveness.<h4>Methods</h4>This study is a secondary analysis from SALOME, a double-blind, phase III, randomized controlled trial testing the non-inferiorirty of injectable hydromorphone to injectable diacetylmorphine among ...[more]

PMID: 28526048

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Project description:BACKGROUND:Social functioning (SF), the ability to engage with life and fulfill roles may be a salient "patient important outcome" in addiction treatment. It is not known if medication-assisted treatment (MAT) impacts SF in opioid use disorder (OUD). There is a growing evidence to suggest that men and women are impacted differently by OUD. This study is the largest to date to study sex differences in OUD and explore associations between MAT and SF. METHODS:Data were collected from 2736 participants with OUD, enrolled in MAT for varying lengths of time, in outpatient clinics across Ontario. SF was defined according to the Maudsley Addiction Profile's domains of (1) employment, (2) criminal activity, and (3) interpersonal conflict. Using logistic regression analysis, we examined sociodemographic and clinical factors associated with domains of SF. RESULTS:There were 1544 men (56%) and 1192 women (44%) in this study, and ages varied from 17 to 76 years for men and 18 to 69 years for women. At study entry, participants had been on MAT for a median of 2 years. Compared to men, women reported more psychological (mean MAP score 14/40, SD = 9.55, versus 11/40, SD = 8.64; p < 0.001) and physical symptoms (mean MAP score 17/40, SD = 7.70 versus 14/40, SD = 7.74; p < 0.001). More women reported unemployment(74% versus 58%; p < 0.0001) and interpersonal conflict (46% versus 35%; p < 0.0001). Men were more likely than women to report criminal activity (11%, versus 8%; p = 0.001). Psychological symptoms increased the risk of worse SF, across domains, for men and for women. Every year on MAT was associated with a 7% increase in the odds of women engaging with criminal activity (OR = 1.07, 95% CI 1.02, 1.12, p = 0.006). CONCLUSIONS:Men and women had different SF profiles and psychological symptoms scores while on MAT. The length of time on MAT increased the risk of criminal activity in women, and overall, duration of MAT was not associated with improvement in SF. This may suggest that MAT alone may not support continual improvements in SF in OUD.

Project description:IntroductionInjectable opioid agonist treatment (iOAT) with diacetylmorphine is an effective option for individuals previously considered non-responsive to opioid substitution treatment. Despite implementation in Canada and several European countries, relatively few eligible people choose to initiate iOAT. To better understand what encourages or deters prospective patients from initiating iOAT, the current study explores patients' perceptions on iOAT and how these influence therapy initiation in practice.MethodsWe conducted 34 semi-structured interviews with individuals currently in or eligible for iOAT in two German outpatient iOAT clinics. Transcripts were analysed following qualitative content analysis, with development of inductive categories and use of consensual coding. For member checking, we consulted individuals with lived experiences prior to data collection and publication.ResultsParticipants based their choice to initiate iOAT on the perceived implications of the treatment on one's daily life and individual recovery. Participants were encouraged to initiate iOAT due to the therapy's perceived potential in reducing cravings and substance use, its positive health consequences, and due to the image of iOAT as a path towards abstinence. Regarding deterring perceptions, participants feared a profound impairment of daily life due to factors such as the daily visits to the clinic, were concerned about whether iOAT would sufficiently promote or even impede one's recovery, and described negative health effects.ConclusionPerceptions found in this study profoundly influenced participants' decisions on iOAT enrolment and contextualize the previous literature. The study reveals the dynamic coexistence of different perceptions about iOAT and sheds light on the inner-group stigmatization of iOAT. Practitioners and future research should acknowledge the complexities found in the current study in order to exploit the full potential of effective treatment modalities such as iOAT.

Project description:IntroductionIllicit opioid use has become a national crisis in Canada, with over 65 000 people seeking treatment for opioid use disorder (OUD) in Ontario and British Columbia alone. Medication-assisted treatment (MAT) is a common treatment for OUD. There is substantial variability in treatment outcomes used to evaluate effectiveness of MAT, making it difficult to establish clinically and scientifically relevant treatment effect. Furthermore, patients are often excluded from the process of determining these outcomes. The primary objective of this review is to examine outcomes currently used to measure MAT effectiveness and to identify patient-relevant outcomes to enhance effectiveness of treatment options. This review refers to patient-important outcomes as those outcomes patients consider important to or markers of treatment success.Methods and analysisMEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Web of Science, Cochrane Library, Cochrane Clinical Trials Registry, National Institutes for Health Clinical Trials Registry and WHO International Clinical Trials Registry Platform databases will be searched. We will search databases from inception to the date the search is ran. Studies of interest include those evaluating the effectiveness of MAT for patients with OUD, with or without consultation with patients regarding what they consider to be important as an indicator of treatment success. Results will be analysed using thematic analysis and qualitative analysis where possible. This will result in comprehensive synthesis of all outcomes and measures found related to OUD treatment effectiveness.Ethics and disseminationWe are collaborating with Canadian Addiction Treatment Centres which provide MAT to patients with OUD who will participate in disseminating study results. Dissemination strategies will involve sharing study results through workshops, presentations, peer-reviewed publications, study reports, community presentations and resources in primary care settings.Prospero registration numberCRD42018095553.

Project description:Background: Opioids accounted for 75% of drug overdoses in the United States in 2020, with rural states particularly impacted by the opioid crisis. While medication assisted treatment (MAT) with Suboxone remains one of the more efficacious treatments for opioid use disorder (OUD), approximately 40% of people receiving Suboxone for outpatient MAT for OUD (MOUD) relapse within the first 6 months of treatment. We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes. The aims of this study are to (1) evaluate the efficacy of adjunctive OptiMAT use in reducing opioid misuse among people receiving MOUD; and (2) evaluate the role of specific OpitMAT features in reducing opioid misuse, including the use of GPS-driven just-in-time intervention. Methods: We will conduct a two-arm, single-blind, randomized controlled trial of adults receiving outpatient MOUD in the greater Little Rock AR area. Participants are English-speaking adults ages 18 or older recently enrolled in outpatient MOUD at one of our participating study clinics. Participants will be allocated via 1:1 randomized block design to (1) MOUD with adjunctive use of OptiMAT (MOUD+OptiMAT) or (2) MOUD without OptiMAT (MOUD-only). Our blinded research statistician will evaluate differences between the two groups in opioid misuse (as determined by quantitative urinalysis conducted by clinical lab staff blinded to group membership) during the 6-months following study enrolment. Secondary analyses will evaluate if OptiMAT-usage patterns within the MOUD+OptiMAT group predict opioid misuse or continued abstinence. Discussion: This study will test if adjunctive use of OptiMAT improve MOUD outcomes. Study findings could lead to expansion of OptiMAT into rural clinical settings, and the identification of OptiMAT features which best predict positive clinical outcome could lead to refinement of this and similar smartphone appbased interventions. Trial registration: ClinicalTrials.gov identifier: NCT05336188, registered March 21, 2022, https://clinicaltrials.gov/ct2/show/NCT05336188.

Project description:BackgroundOpioids accounted for 75% of drug overdoses in the USA in 2020, with rural states particularly impacted by the opioid crisis. While medication-assisted treatment (MAT) with Suboxone remains one of the more efficacious treatments for opioid use disorder (OUD), approximately 40% of people receiving Suboxone for outpatient MAT for OUD (MOUD) relapse within the first 6 months of treatment. We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes. The aims of this study are to (1) evaluate the efficacy of adjunctive OptiMAT use in reducing opioid misuse among people receiving MOUD and (2) evaluate the role of specific OptiMAT features in reducing opioid misuse, including the use of GPS-driven just-in-time intervention.MethodsWe will conduct a two-arm, single-blind, randomized controlled trial of adults receiving outpatient MOUD in the greater Little Rock AR area. Participants are English-speaking adults ages 18 or older recently enrolled in outpatient MOUD at one of our participating study clinics. Participants will be allocated via 1:1 randomized block design to (1) MOUD with adjunctive use of OptiMAT (MOUD+OptiMAT) or (2) MOUD without OptiMAT (MOUD-only). Our blinded research statistician will evaluate differences between the two groups in opioid misuse (as determined by quantitative urinalysis conducted by clinical lab staff blinded to group membership) during the 6-months following study enrolment. Secondary analyses will evaluate if OptiMAT-usage patterns within the MOUD+OptiMAT group predict opioid misuse or continued abstinence.DiscussionThis study will test if adjunctive use of OptiMAT improve MOUD outcomes. Study findings could lead to expansion of OptiMAT into rural clinical settings, and the identification of OptiMAT features which best predict positive clinical outcome could lead to refinement of this and similar smartphone app-based interventions.Trial registrationClinicalTrials.gov identifier: NCT05336188 , registered March 21, 2022.

Project description:AIMS:To review systematically the published literature on extended-release naltrexone (XR-NTX, Vivitrol® ), marketed as a once-per-month injection product to treat opioid use disorder. We addressed the following questions: (1) how successful is induction on XR-NTX; (2) what are adherence rates to XR-NTX; and (3) does XR-NTX decrease opioid use? Factors associated with these outcomes as well as overdose rates were examined. METHODS:We searched PubMed and used Google Scholar for forward citation searches of peer-reviewed papers from January 2006 to June 2017. Studies that included individuals seeking treatment for opioid use disorder who were offered XR-NTX were included. RESULTS:We identified and included 34 studies. Pooled estimates showed that XR-NTX induction success was lower in studies that included individuals that required opioid detoxification [62.6%, 95% confidence interval (CI) = 54.5-70.0%] compared with studies that included individuals already detoxified from opioids (85.0%, 95% CI = 78.0-90.1%); 44.2% (95% CI = 33.1-55.9%) of individuals took all scheduled injections of XR-NTX, which were usually six or fewer. Adherence was higher in prospective investigational studies (i.e. studies conducted in a research context according to a study protocol) compared to retrospective studies of medical records taken from routine care (6-month rates: 46.7%, 95% CI = 34.5-59.2% versus 10.5%, 95% CI = 4.6-22.4%, respectively). Compared with referral to treatment, XR-NTX reduced opioid use in adults under criminal justice supervision and when administered to inmates before release. XR-NTX reduced opioid use compared with placebo in Russian adults, but this effect was confounded by differential retention between study groups. XR-NTX showed similar efficacy to buprenorphine when randomization occurred after detoxification, but was inferior to buprenorphine when randomization occurred prior to detoxification. CONCLUSIONS:Many individuals intending to start extended-release naltrexone (XR-NTX) do not and most who do start XR-NTX discontinue treatment prematurely, two factors that limit its clinical utility significantly. XR-NTX appears to decrease opioid use but there are few experimental demonstrations of this effect.

Dataset Information

Men's and women's response to treatment and perceptions of outcomes in a randomized controlled trial of injectable opioid assisted treatment for severe opioid use disorder.

Publications

Men's and women's response to treatment and perceptions of outcomes in a randomized controlled trial of injectable opioid assisted treatment for severe opioid use disorder.

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