Evaluating comparative effectiveness of psychosocial interventions for persons receiving opioid agonist therapy for opioid use disorder: protocol for a systematic review.
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ABSTRACT: Introduction
The opioid crisis has resulted in increasing rates of death caused by problematic opioid use. Current clinical guidelines recommend that individuals with persons with opioid use disorder (OUD) receive pharmacological (eg, opioid agonist therapy) and psychosocial (eg, cognitive behavioural therapy) therapy; however, the best combination of pharmacologic and psychosocial components is not known. Our objective of the planned study is to conduct a comprehensive systematic review to assess the relative benefits of psychosocial interventions as an adjunct to opioid agonist therapy among persons with OUD.Methods and analysis
A comprehensive search for randomised controlled trials published in English or French will be conducted from database inception to March 2018. The search will be conducted in MEDLINE and translated for Embase, PsycINFO and the Cochrane Central Register of Controlled Trials. Two independent reviewers will screen, extract and assess risk of bias of eligible articles. Primary outcomes of interest will be treatment retention and opioid use (based on urinalysis results). Secondary outcomes will include self-reported opioid use, abstinence from illicit drugs, adherence to psychosocial therapy and opioid agonist therapy, risk for sexually transmitted disease, risk for blood borne pathogens, changes in mental health symptoms (eg, depression), measures of craving and changes in patients' quality of life and relevant adverse events. If sufficient data and adequate homogeneity exists, network meta-analyses (NMA) will be performed.Ethics and dissemination
This will be the first systematic review to incorporate NMA to compare psychosocial treatments used as an adjunct to opioid agonist therapy for OUD. Results of this review will inform clinical management of persons with OUD.Trial registration number
CRD42018090761.
SUBMITTER: Rice DB
PROVIDER: S-EPMC6196951 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundGuidelines recommend that individuals with opioid use disorder (OUD) receive pharmacological and psychosocial interventions; however, the most appropriate psychosocial intervention is not known. In collaboration with people with lived experience, clinicians, and policy makers, we sought to assess the relative benefits of psychosocial interventions as an adjunct to opioid agonist therapy (OAT) among persons with OUD.MethodsA review protocol was registered a priori (CRD42018090761), and a comprehensive search for randomized controlled trials (RCT) was conducted from database inception to June 2020 in MEDLINE, Embase, PsycINFO and the Cochrane Central Register of Controlled Trials. Established methods for study selection and data extraction were used. Primary outcomes were treatment retention and opioid use (measured by urinalysis for opioid use and opioid abstinence outcomes). Odds ratios were estimated using network meta-analyses (NMA) as appropriate based on available evidence, and in remaining cases alternative approaches to synthesis were used.ResultsSeventy-two RCTs met the inclusion criteria. Risk of bias evaluations commonly identified study limitations and poor reporting with regard to methods used for allocation concealment and selective outcome reporting. Due to inconsistency in reporting of outcome measures, only 48 RCTs (20 unique interventions, 5,404 participants) were included for NMA of treatment retention, where statistically significant differences were found when psychosocial interventions were used as an adjunct to OAT as compared to OAT-only. The addition of rewards-based interventions such as contingency management (alone or with community reinforcement approach) to OAT was superior to OAT-only. Few statistically significant differences between psychosocial interventions were identified among any other pairwise comparisons. Heterogeneity in reporting formats precluded an NMA for opioid use. A structured synthesis was undertaken for the remaining outcomes which included opioid use (n = 18 studies) and opioid abstinence (n = 35 studies), where the majority of studies found no significant difference between OAT plus psychosocial interventions as compared to OAT-only.ConclusionsThis systematic review offers a comprehensive synthesis of the available evidence and the limitations of current trials of psychosocial interventions applied as an adjunct to OAT for OUD. Clinicians and health services may wish to consider integrating contingency management in addition to OAT for OUD in their settings to improve treatment retention. Aside from treatment retention, few differences were consistently found between psychosocial interventions adjunctive to OAT and OAT-only. There is a need for high-quality RCTs to establish more definitive conclusions.Trial registrationPROSPERO registration CRD42018090761.
| S-EPMC7769275 | biostudies-literature
Project description:The opioid and cannabinoid receptor systems are inextricably linked-overlapping at the anatomical, functional and behavioural levels. Preclinical studies have reported that cannabinoid and opioid agonists produce synergistic antinociceptive effects. Still, there are no experimental data on the effects of cannabinoid agonists among humans who receive opioid agonist therapies for opioid use disorder (OUD). We conducted an experimental study to investigate the acute effects of the delta-9-tetrahydrocannabinol (THC) among persons receiving methadone therapy for OUD. Using a within-subject, crossover, human laboratory design, 25 persons on methadone therapy for OUD (24% women) were randomly assigned to receive single oral doses of THC (10 or 20 mg, administered as dronabinol) or placebo, during three separate 5-h test sessions. Measures of experimental and self-reported pain sensitivity, abuse potential, cognitive performance and physiological effects were collected. Mixed-effects models examined the main effects of THC dose and interactions between THC (10 and 20 mg) and methadone doses (low-dose methadone defined as <90 mg/day; high dose defined as >90 mg/day). Results demonstrated that, for self-reported rather than experimental pain sensitivity measures, 10 mg THC provided greater relief than 20 mg THC, with no substantial evidence of abuse potential, and inconsistent dose-dependent cognitive adverse effects. There was no indication of any interaction between THC and methadone doses. Collectively, these results provide valuable insights for future studies aiming to evaluate the risk-benefit profile of cannabinoids to relieve pain among individuals receiving opioid agonist therapy for OUD, a timely endeavour amidst the opioid crisis.
| S-EPMC10468603 | biostudies-literature
Project description:ImportanceGiven the high number of opioid overdose deaths in the US and the complex epidemiology of opioid use disorder (OUD), systems models can serve as a tool to identify opportunities for public health interventions.ObjectiveTo estimate the projected 3-year association between public health interventions and opioid overdose-related outcomes among persons with OUD.Design, setting, and participantsThis decision analytical model used a simulation model of the estimated US population aged 12 years and older with OUD that was developed and analyzed between January 2019 and December 2023. The model was parameterized and calibrated using 2019 to 2020 data and used to estimate the relative change in outcomes associated with simulated public health interventions implemented between 2021 and 2023.Main outcomes and measuresProjected OUD and medications for OUD (MOUD) prevalence in 2023 and number of nonfatal and fatal opioid-involved overdoses among persons with OUD between 2021 and 2023.ResultsIn a baseline scenario assuming parameters calibrated using 2019 to 2020 data remained constant, the model projected more than 16 million persons with OUD not receiving MOUD treatment and nearly 1.7 million persons receiving MOUD treatment in 2023. Additionally, the model projected over 5 million nonfatal and over 145 000 fatal opioid-involved overdoses among persons with OUD between 2021 and 2023. When simulating combinations of interventions that involved reducing overdose rates by 50%, the model projected decreases of up to 35.2% in nonfatal and 36.6% in fatal opioid-involved overdoses among persons with OUD. Interventions specific to persons with OUD not currently receiving MOUD treatment demonstrated the greatest reduction in numbers of nonfatal and fatal overdoses. Combinations of interventions that increased MOUD initiation and decreased OUD recurrence were projected to reduce OUD prevalence by up to 23.4%, increase MOUD prevalence by up to 137.1%, and reduce nonfatal and fatal opioid-involved overdoses among persons with OUD by 6.7% and 3.5%, respectively.Conclusions and relevanceIn this decision analytical model study of persons with OUD, findings suggested that expansion of evidence-based interventions that directly reduce the risk of overdose fatality among persons with OUD, such as through harm reduction efforts, could engender the highest reductions in fatal overdoses in the short-term. Interventions aimed at increasing MOUD initiation and retention of persons in treatment projected considerable improvement in MOUD and OUD prevalence but could require a longer time horizon for substantial reductions in opioid-involved overdoses.
| S-EPMC10993074 | biostudies-literature
Project description:Background and aimsEvidence from randomized controlled trials establishes that medication treatment with methadone and buprenorphine reduces opioid use and improves treatment retention. However, little is known about the role of such medications compared with non-medication treatments in mitigating overdose risk among US patient populations receiving treatment in usual care settings. This study compared overdose mortality among those in medication versus non-medication treatments in specialty care settings.DesignRetrospective cohort study using state-wide treatment data linked to death records. Survival analysis was used to analyze data in a time-to-event framework.SettingServices delivered by 757 providers in publicly funded out-patient specialty treatment programs in Maryland, USA between 1 January 2015 and 31 December 2016.ParticipantsA total of 48 274 adults admitted to out-patient specialty treatment programs in 2015-16 for primary diagnosis of opioid use disorder.MeasurementsMain exposure was time in medication treatment (methadone/buprenorphine), time following medication treatment, time exposed to non-medication treatments and time following non-medication treatment. Main outcome was opioid overdose death during and after treatment. Hazard ratios were calculated using Cox proportional hazard regression. Propensity score weights were adjusted for patient information on sex, age, race, region of residence, marital and veteran status, employment, homelessness, primary opioid, mental health treatment, arrests and criminal justice referral.FindingsThe study population experienced 371 opioid overdose deaths. Periods in medication treatment were associated with substantially reduced hazard of opioid overdose death compared with periods in non-medication treatment [adjusted hazard ratio (aHR) = 0.18, 95% confidence interval (CI) = 0.08-0.40]. Periods after discharge from non-medication treatment (aHR = 5.45, 95% CI = 2.80-9.53) and medication treatment (aHR = 5.85, 95% CI = 3.10-11.02) had similar and substantially elevated risks compared with periods in non-medication treatments.ConclusionsAmong Maryland patients in specialty opioid treatment, periods in treatment are protective against overdose compared with periods out of care. Methadone and buprenorphine are associated with significantly lower overdose death compared with non-medication treatments during care but not after treatment is discontinued.
| S-EPMC7426244 | biostudies-literature
Project description:Physical exercise (PE) has not been well studied in persons living with HIV (PLHIV). We conducted an overview of systematic reviews to assess the effectiveness of PE and to determine the most appropriate PE regimen for PLHIV. We used the CDC's Prevention Research Synthesis Project's database and manual searches to identify systematic reviews published between 1996 and 2013. We qualitatively synthesized the findings from five reviews to assess the effectiveness of PE and conducted meta-analyses on CD4 counts to identify the best PE regimen. PE is associated with reduced adiposity and depression, but was not associated with a decrease in HIV viral load. CD4 counts were improved by interventions with interval aerobic or 41-50 minutes of exercise three times per week compared with other modes and duration of exercise. PE appears to benefit PLHIV, but more research is needed to help develop appropriate PE strategies specifically for PLHIV.
| S-EPMC5942186 | biostudies-other
Project description:BackgroundTreating acute pain among persons with opioid use disorder (OUD) on opioid agonist therapy (OAT) is complex, and the therapeutic benefits of opioids remain unclear when weighted against their abuse potential and respiratory depressant effects.MethodsWe conducted a systematic review of experimental pain studies examining opioid-induced analgesia among persons with OUD on OAT. We searched multiple databases from inception to July 30, 2021. Study quality was assessed by previously established validity measures.ResultsNine studies were identified, with a total of 225 participants, of whom 63% were male, and 37% were female. Six studies included methadone-maintained persons with OUD; four studies included buprenorphine-maintained persons with OUD; and three studies included healthy persons as comparison groups. Either additional doses of OAT or other opioids - morphine, oxycodone, hydromorphone, or remifentanil - were administered. In seven studies, persons with OUD on OAT did not experience analgesia, despite receiving opioid doses up to 20 times greater than those clinically used to treat severe pain among the opioid naïve. Conversely, in two studies, high-potency opioids did produce analgesia, albeit with greater abuse potential. Notably, persons with OUD on OAT remained vulnerable to respiratory depression.ConclusionsAlthough persons with OUD on OAT can derive analgesic effects from opioids, high-potency compounds may be required to achieve clinically significant pain relief. Further, persons with OUD on OAT may remain vulnerable to opioid-induced abuse potential and respiratory depression. Together, these finding have clinical, methodological, and mechanistic implications for the treatment of acute pain in the context of OAT.
| S-EPMC8595687 | biostudies-literature
Project description:Introduction and objectiveReceipt of opioid agonist treatment during early and late pregnancy for opioid use disorder may relate to varying perinatal risks. We aimed to assess the effect of time-varying prenatal exposure to opioid agonist treatment using buprenorphine or methadone on adverse neonatal and pregnancy outcomes.MethodsWe conducted a retrospective cohort study of pregnant women with opioid use disorder using Rhode Island Medicaid claims data and vital statistics during 2008-16. Time-varying exposure was evaluated in early (0-20 weeks) and late (≥ 21 weeks) pregnancy. Marginal structural models with inverse probability of treatment weighting were applied.ResultsOf 400 eligible pregnancies, 85 and 137 individuals received buprenorphine and methadone, respectively, during early pregnancy. Compared with 152 untreated pregnancies with opioid use disorders, methadone exposure in both periods was associated with an increased risk of preterm birth (adjusted odds ratio [aOR]: 2.52; 95% confidence interval [CI] 1.07-5.95), low birth weight (aOR: 2.99; 95% CI 1.34-6.66), neonatal intensive care unit admission (aOR, 5.04; 95% CI 2.49-10.21), neonatal abstinence syndrome (aOR: 11.36; 95% CI 5.65-22.82), respiratory symptoms (aOR, 2.71; 95% CI 1.17-6.24), and maternal hospital stay > 7 days (aOR, 14.51; 95% CI 7.23-29.12). Similar patterns emerged for buprenorphine regarding neonatal abstinence syndrome (aOR: 10.27; 95% CI 4.91-21.47) and extended maternal hospital stay (aOR: 3.84; 95% CI 1.83-8.07). However, differences were found favoring the use of buprenorphine for preterm birth versus untreated pregnancies (aOR: 0.17; 95% CI 0.04-0.77), and for several outcomes versus methadone.ConclusionsMethadone and buprenorphine prescribed for the treatment of opioid use disorder during pregnancy are associated with varying perinatal risks. However, buprenorphine may be preferred in the setting of pregnancy opioid agonist treatment. Further research is necessary to confirm our findings and minimize residual confounding.
| S-EPMC10363992 | biostudies-literature
Project description:ObjectiveThe study examined whether the use of opioid agonist therapy (OAT) for treatment of opioid use disorder in specialty substance use treatment settings increased following Medicaid expansion.MethodsAdministrative data on 943,430 admissions from the Treatment Episodes Data Set-Admissions (2010-2016) were used to examine the association between Medicaid expansion and the use of OAT and to assess whether this association was mediated by increased proportion of admissions with Medicaid in expansion states.ResultsFrom 2010-2013 to 2014-2016, OAT use among patients with opioid use disorder increased in both expansion (39.1% and 50.2%, respectively) and nonexpansion (39.9% and 40.5%, respectively) states. The effect of Medicaid expansion on OAT use was mainly mediated through a larger proportion of admissions with Medicaid in expansion states.ConclusionsAs the nation grapples with the opioid epidemic, expanding Medicaid coverage has the potential to promote greater access to evidence-based treatment.
| S-EPMC6602831 | biostudies-literature
Project description:ImportanceOpioid-stimulant co-use is a common problem with few evidence-based treatments.ObjectiveTo examine bupropion slow release (SR) enhancement of a tailored abstinence incentive program for stimulant use in persons with opioid use disorder.Design, setting, and participantsThis 26-week, double-blind, placebo-controlled randomized clinical trial with a 4-week follow-up period was conducted at 4 methadone treatment programs in Baltimore, Maryland. Included participants were persons receiving methadone for the treatment of opioid use disorder with past 3-month cocaine use and current cocaine use disorder between March 2015 and September 2019. Data were analyzed from November 2020 through August 2022.InterventionsA 6-week incentive induction period with monetary incentives for evidence of cocaine abstinence during thrice-weekly urine testing was conducted. Persons achieving 2 weeks of consecutive abstinence during induction were assigned to the relapse prevention group (20 individuals); otherwise, individuals were assigned to the abstinence initiation group (60 individuals). Participants were randomized within incentive groups to bupropion SR (150 mg oral twice daily; 40 participants) or placebo (40 participants). Incentives were available until week 26, and study medication ended week 30.Main outcomes and measuresThe mean percentage of participants with cocaine abstinence (by negative urinalysis or self-report) during weeks 7 to 26 (ie, the incentive intervention period) and 27 to 30 (ie, the follow-up period) and the percentage of participants testing negative for cocaine at weeks 26 and 30 were assessed. Main effects of medication collapsed across incentive conditions and sensitivity analyses of medications within incentive conditions were assessed. Analyses were conducted in the modified intention-to-treat sample (ie, 80 individuals who received ≥1 dose of study medication) and completers (ie, 52 individuals who completed ≥1 visit during week 30).ResultsAmong 80 participants (42 Black [52.5% ] and 35 White [43.8%]; mean [SD] age, 45.7 (9.4) years; 52 males [65.0%]) receiving methadone for opioid use disorder, 40 participants were randomized to receive bupropion SR and 40 participants to receive placebo. No significant difference on urinalysis or self-reported cocaine use was observed between medication groups. Sensitivity analyses revealed differential patterns for incentive subgroups. Participants in the relapse prevention group had high abstinence (>80%; eg, during weeks 7-26 in the modified intention-to-treat analysis, 410 of 456 samples [89.9%] from participants in the bupropion SR group tested negative for cocaine) throughout the trial regardless of whether they were randomized to bupropion SR or placebo. Participants in the abstinence initiation group had better outcomes with bupropion SR than placebo throughout the trial (mean [SD] total number of samples testing negative for cocaine, 30.3 [21.6] samples for bupropion SR vs 17.1 [14.9] samples for placebo; P = .05) and more participants receiving bupropion SR than placebo were abstinent at the end of the study (20 of 30 participants [66.7%] vs 9 of 30 participants [30.0%]; P = .04).Conclusions and relevanceIn this randomized clinical trial, an overall benefit for bupropion SR vs placebo when combined with a financial abstinence incentive program was not observed. Results among incentive subgroups suggest that continued evaluation of medications, including bupropion SR, for stimulant treatment using a tailored approach that factors early abstinence into study design and interpretation may be needed.Trial registrationClinicalTrials.gov Identifier: NCT02111798.
| S-EPMC10018324 | biostudies-literature
Project description:Cannabis use has been continuously increasing, and cannabis use disorder (CUD) has become a public health issue. Some psychosocial interventions have demonstrated the ability to reduce cannabis use; however, there are no pharmacotherapies approved for the treatment of CUD. Some drugs have shown limited positive effects on use and withdrawal symptoms, but no controlled studies have been able to show strong and persistent effects on clinically meaningful outcomes. The aim of this review is to synthesize the evidence from the available literature regarding the effectiveness of psychosocial and pharmacological treatments for CUD among adults (that is, 18 years old or older). An analysis of the evidence shows that the current best psychosocial intervention to reduce cannabis use is the combination of motivational enhancement therapy and cognitive-behavioral therapy, preferably accompanied by a contingency management approach. In regard to pharmacological interventions, there are mostly unclear findings. Some drugs, such as CB1 agonists, gabapentin, and N-acetylcysteine, have been shown to produce improvements in some symptoms of CUD in single studies, but these have not been replicated. Other classes of medications, including antidepressants and antipsychotics, have been unsuccessful in producing such effects. There is an imminent need for more clinical trials to develop more effective treatments for CUD.
| S-EPMC5811668 | biostudies-other