A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification.
ABSTRACT: Detoxification with psychosocial counseling remains a standard opioid-use disorder treatment practice but is associated with poor outcomes. This study tested the efficacy of a newly developed psychosocial intervention, Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T), relative to psychosocial treatment as usual (TAU), for improving treatment outcomes.A randomized, 14-week trial with follow-up visits at 6 and 9 months post-randomization conducted at two substance use disorder (SUD) treatment programs. Opioid-dependent adults (i.e., identified patient - IP) enrolled in a residential buprenorphine-detoxification program and their identified concerned significant other (CSO) was randomized to CRAFT-T (n=28 dyads) or TAU (n=24 dyads). CRAFT-T consisted of two sessions with the IP and CSO together and 10 with the CSO alone, over 14 weeks. TAU for the CSOs was primarily educational and referral to self-help. All IPs received treatment as usually provided by the SUD program in which they were enrolled. The primary outcome was time to first IP drop from treatment lasting 30 days or more. Opioid and other drug use were key secondary outcomes.CRAFT-T resulted in a moderate but non-significant effect on treatment retention (p=0.058, hazard ratio=0.57). When the CSO was parental family, CRAFT-T had a large and significant effect on treatment retention (p<0.01, hazard ratio=.040). CRAFT-T had a significant positive effect on IP opioid and other drug use (p<0.0001).CRAFT-T is a promising treatment for opioid use disorder but replication is needed to confirm these results.
Project description:BACKGROUND:Facing an epidemic of opioid-related mortality, many government health departments, insurers, and treatment providers have attempted to expand patient access to buprenorphine in psychosocial substance use disorder (SUD) programs and medical settings. METHODS:With Missouri Medicaid data from 2008 to 2015, we used Cox proportional hazard models to estimate the relative hazards for treatment attrition and SUD-related emergency department (ED) visits or hospitalizations associated with buprenorphine in psychosocial SUD programs and medical settings. We also tested the association of buprenorphine with hours of psychosocial treatment during the first 30?days of psychosocial SUD treatment. The analytic sample included claims from 7606 individuals with an OUD diagnosis. RESULTS:Compared to psychosocial treatment without buprenorphine (PSY), the addition of buprenorphine (PSY-B) was associated with a significantly reduced hazard for treatment attrition (adjusted hazard ratio: 0.67, 95% CI: 0.62-0.71). Among buprenorphine episodes, office-based (B-OBOT), outpatient hospital (B-OPH), and no documented setting (B-PHA) were associated with reduced hazards for treatment attrition when compared to the psychosocial SUD setting (B-PSY) (adjusted hazard ratios: 0.27, 95% CI: 0.24-0.31; 0.46, 95% CI: 0.39-0.54; 0.70, 95% CI: 0.61-0.81). Compared to B-PSY, B-OBOT and B-PHA were associated with significantly reduced hazards for a SUD-related ED visits or hospitalization (adjusted hazard ratios: 0.59, 95% CI: 0.41-0.85; 0.53, 95% CI: 0.36-0.78). There was no significant difference between B-PSY and B-OPH or B-PSY and PSY in hazard for an SUD-related ED visit or hospitalization. CONCLUSIONS:Our findings support the conclusion that adding buprenorphine to Medicaid-covered psychosocial SUD treatment reduces patient attrition and SUD-related ED visits or hospitalizations but that buprenorphine treatment in office-based medical settings is even more effective in reducing these negative outcomes. Policy-makers should consider ways to expand buprenorphine access in all settings, but particularly in office-based medical settings. Buprenorphine treatment in an unbilled setting was associated with an increased hazard for patient attrition when compared to treatment in billed medical settings, indicating the importance of Medicaid-covered provider visits for patient retention.
Project description:BACKGROUND:Drug-based therapeutic approaches for Parkinson's disease dementia (PDD) and dementia with Lewy bodies (DLB) are moderately effective and not always tolerated. Tailoring psychosocial approaches in PDD and DLB may offer additional support and improve outcomes. We adapted home-based, care partner-delivered Cognitive Stimulation Therapy (CST) for individuals with PDD or DLB and their care partners (CST-PD). OBJECTIVES:To evaluate the feasibility, acceptability, and tolerability of CST-PD. METHODS:This randomised controlled trial used mixed methods, including a process evaluation. People with PDD, DLB or mild cognitive impairment in PD (PD-MCI) and their care partners were randomised to 12 weeks of treatment as usual (TAU) or CST-PD. Outcomes were feasibility of the study conduct (i.e., recruitment, retention rate) and acceptability and tolerability of the intervention. Measures included rating scales, researcher field notes, therapy diaries, and exploratory clinical and care partner efficacy measures. RESULTS:The recruitment target was met with 76 consenting participant-dyads. Retention in both arms was high at over 70%. More than 90% of dyads undertook discrete sessions greater than 20 min duration, but the average number of sessions completed was lower than the recommended dose. Acceptability ratings (i.e., interest, motivation and sense of achievement) of the intervention were high. Participants reported no serious adverse events related to the intervention. CONCLUSIONS:The field of psychosocial interventions for PDD and DLB is newly emerging, and we demonstrated that this type of intervention is acceptable and well tolerated. Evaluating its clinical effectiveness in a full-scale randomized controlled clinical trial is warranted. TRIAL REGISTRATION NUMBER:The trial is a psychosocial intervention with an allocated ISRCTN number 11455062.
Project description:Background: Counselor workforce turnover is a critical area of concern for substance use disorder (SUD) treatment providers and researchers. To facilitate the adoption and implementation of innovative treatments, attention must be paid to how SUD treatment workforce issues affect the implementation of clinical effectiveness research. Multiple variables have been shown to relate to turnover, yet reasons that are specific to conducting research have not been systematically assessed. Methods: In a randomized clinical trial testing a sexual risk reduction counselor training intervention, 69 counselors at 4 outpatient SUD treatment sites (2 opioid treatment programs [OTPs], 2 psychosocial) were enrolled and randomized to 1 of 2 training conditions (Standard vs. Enhanced). Study counselor and agency turnover rates were calculated. Agency context and policies that impacted research participation were examined. Results: Study turnover rates for enrolled counselors were substantial, ranging from 33% to 74% over approximately a 2-year active study period. Study counselor turnover was significantly greater at outpatient psychosocial programs versus OTPs. Counselor turnover did not differ due to demographic or training condition assignment. Leaving agency employment was the most typical reason for study counselor turnover. Conclusions: This secondary analysis used data from a multisite study with frontline counselors to provide a qualitative description of challenges faced when conducting effectiveness research in SUD treatment settings. That counselors may be both subjects and deliverers of the interventions studied in clinical trials, with implications for differential impact on study implementation, is highlighted. We offer suggestions for researchers seeking to implement effectiveness research in SUD clinical service settings.
Project description:BACKGROUND:This randomized controlled trial (RCT) investigated the effectiveness of a combined treatment for co-morbid Posttraumatic Stress Disorder (PTSD) and severe Substance Use Disorder (SUD). METHODS:Structured Writing Therapy for PTSD (SWT), an evidence-based traumafocused intervention, was added on to Treatment As Usual (TAU), consisting of an intensive cognitive behavioral inpatient or day group treatment for SUD. The outcomes of the combined treatment (TAU + SWT) were compared to TAU alone in a sample of 34 patients. RESULTS:Results showed a general reduction of SUD symptoms for both TAU + SWT and TAU. Treatment superiority of TAU + SWT was neither confirmed by interaction effects (time x condition) for SUD or PTSD symptoms, nor by a group difference for SUD diagnostic status at post-treatment. However, planned contrasts revealed that improvements for PTSD severity over time were only significant within the TAU + SWT group. In addition, within the TAU + SWT group the remission of PTSD diagnoses after treatment was significant, which was not the case for TAU. Finally, at post-treatment a trend was noticed for between group differences for the number of PTSD diagnoses favoring TAU + SWT above TAU. CONCLUSIONS:In sum, the current study provides preliminary evidence that adding a trauma-focused treatment on to standard SUD treatment may be beneficial.
Project description:<h4>Background</h4>Guidelines 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.<h4>Methods</h4>A 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.<h4>Results</h4>Seventy-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.<h4>Conclusions</h4>This 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.<h4>Trial registration</h4>PROSPERO registration CRD42018090761.
Project description:BACKGROUND:Treatment completion is the greatest challenge for the treatment of substance use disorders (SUDs). A previous investigation showed that complementary horse-assisted therapy (cHAT) was associated with higher retention in treatment and completion than standard treatment alone. This randomized controlled trial further explored the benefits of cHAT for patients with SUDs. METHODS:Fifty patients in residential SUD treatment at the Department of Addiction Treatment, Oslo University Hospital, were randomly allocated to either cHAT (cHAT group) or treatment as usual alone (TAU-only group). The primary end-point was treatment completion. Secondary end-points were dropout, transfer to another treatment, and time in treatment. RESULTS:The multinomial logistic regression analysis found no statistically significant association between intervention (cHAT) and treatment outcome (completion, dropout, transferred) among the 37 participants who were ultimately recruited to the study. Some unforeseen challenges were encountered in the study: a high number of subjects transferred to another treatment, variable attendance at cHAT sessions, and long temporary exits. Nevertheless, 44% of participants in the cHAT group completed their treatment, compared with 32% in the TAU-only group; this observation encourages further investigation in a larger sample. CONCLUSIONS:Though no association was identified between cHAT and treatment retention or completion, our study may have been underpowered. Further work in a larger clinical population is needed; observational studies with repeated measures may also be useful for investigating whether cHAT increases retention in treatment or rates of completion, two important factors for successful SUD treatment. Trial registration The trial was registered and approved on 14 October 2011 by the Regional Committee for Medical and Health Research Ethics with registration number 2011/1642 and registered at ClinicalTrials.gov on 21 February 2013 with registration number NCT01795755.
Project description:HIV-infected people with substance use disorders are least likely to benefit from advances in HIV treatment. Integration of extended-release naltrexone (XR-NTX) into HIV clinics may increase engagement in the HIV care continuum by decreasing substance use. We aimed to compare (1) XR-NTX treatment initiation, (2) retention and (3) safety of XR-NTX versus treatment as usual (TAU) for treating opioid use disorder (OUD) and/or alcohol use disorder (AUD) in HIV clinics.Non-blinded randomized trial of XR-NTX versus pharmacotherapy TAU.HIV primary care clinics in Vancouver, BC, Canada and Chicago, IL, USA.Fifty-one HIV-infected patients seeking treatment for OUD (n = 16), AUD (n = 27) or both OUD and AUD (n = 8).Primary outcomes were XR-NTX initiation (receipt of first injection within 4 weeks of randomization) and retention at 16 weeks. Secondary outcomes generated point estimates for change in substance use, HIV viral suppression [HIV RNA polymerase chain reaction (pcr) < 200 copies/ml] and safety.Two-thirds (68%) of participants assigned to XR-NTX initiated treatment, and 88% of these were retained on XR-NTX at 16 weeks. In comparison, 96% of TAU participants initiated treatment, but only 50% were retained on medication at 16 weeks. Mean days of opioid use in past 30 days decreased from 17.3 to 4.1 for TAU and from 20.3 to 7.7 for XR-NTX. Mean heavy drinking days decreased from 15.6 to 5.7 for TAU and 12.5 to 2.8 for XR-NTX. Among those with OUD, HIV suppression improved from 67 to 80% for XR-NTX and 58 to 75% for TAU. XR-NTX was well tolerated, with no precipitated withdrawals and one serious injection-site reaction.Extended-release naltrexone (XR-NTX) is feasible and safe for treatment of opioid use disorder and alcohol use disorder in HIV clinics. Treatment initiation appears to be lower and retention greater for XR-NTX compared with treatment as usual (clinicaltrials.gov NCT01908062).
Project description:Although therapeutic treatments exist for substance use disorder (SUD), about half of individuals who enter treatment leave early and relapse to substance use. Early dropout from residential treatment places individuals at risk of relapse, and women in SUD residential treatment represent a vulnerable population. Evidence gaps persist for the use of mindfulness-based interventions (MBIs) among racially and ethnically diverse women with SUDs, especially regarding the efficacy of MBIs adapted to prevent residential dropout and relapse. We previously developed and pilot tested an MBI, Moment-by-Moment in Women's Recovery (MMWR), adapted to support women with SUD during residential treatment. The 12-session MMWR program tested in the present study integrates relapse prevention, addresses literacy level and trauma experiences and mental health problems, and is relevant to issues surrounding treatment- and relapse-related stressors among women. The primary objective of the current Phase II randomized controlled trial is to adequately test the efficacy of MMWR on residential treatment retention and substance use relapse and determine psychosocial and neural mechanisms of action underlying MMWR. Participants are women in residential SUD treatment from a community-based residential site that serves mainly women who are low-income and racially and ethnically diverse. A subgroup of participants from each treatment group also completes functional and structural neuroimaging assessments before and after the intervention to explore possible structural and functional brain correlates of change associated with participation in the MMWR program. Findings are expected to inform the utility of adapting MBIs to improve treatment success among vulnerable women in SUD residential treatment.
Project description:BACKGROUND:Among the adult population worldwide, about 0.5% has illicit drug use disorder (DUD) and about 5% has alcohol use disorder (AUD). Dependency on alcohol, medication or illicit drugs are recognised as risk factors for disabling disease and early death. Treatment for substance use disorders (SUD) is important in promoting persistent abstinence and may be perceived as a valuable public health measure. The current systematic review aims at exploring how psychosocial factors connected to recovery capital and coping behaviour, change after inpatient SUD treatment. METHODS:A systematic search was conducted in Campbell Collaboration Library, Cochrane Library, EMBASE, Epistemonikos, Medline, PsychINFO, Social Sciences Citation Index and SocINDEX. Cohort studies on psychosocial outcomes for adults who had attended to inpatient SUD treatment that exceeds 3 months, were included. The outcome of interest was change in psychosocial factors. The search results were identified as include, exclude or unclear by one author and then screened by the second author with a specific focus on studies recognised as unclear. Diverging evaluations of eligibility among the unclear studies were resolved by discussion. In case of disagreement, the third author decided the eligibility of the studies in question. RESULTS:Findings imply an overall progress in mental health, and a potential improvement in employment status and perceived social support after inpatient SUD treatment. Additionally, findings indicate a decrease in substance use from admission to follow-up after discharge from inpatient SUD treatment. These findings are consistent with earlier research on important factors in recovering from SUD. Findings on change in self-efficacy, housing, education and Quality of Life (QoL) however, were scantly researched and were expected to be more prominent outcomes of interest among the included studies. CONCLUSION:Due to the substantial resources used to provide SUD treatment, knowledge about recovery capital, like psychosocial factors that facilitate coping behaviour and reintegration to society, should be standardised and used by SUD treatment providers. TRIAL REGISTRATION:PROSPERO registration ID: CRD42018087408.
Project description:BACKGROUND:Training in interoceptive awareness is a promising behavioral approach for improving substance use disorder (SUD) treatment. This study examined the longitudinal effects of Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to women's SUD treatment. MABT teaches interoceptive awareness skills to promote self-care and emotion regulation. METHODS:Women in intensive outpatient treatment for SUD at three community clinics were recruited and randomly assigned to one of three study conditions Treatment as Usual (TAU) + MABT, TAU?+?Women's Health Education (WHE), and TAU only. Four assessments were delivered over one year (N?=?187) baseline, 3, 6 and 12 months to examine primary outcome of percent days abstinent from substance use, and secondary outcomes of emotion dysregulation, craving, psychological distress, mindfulness and interoceptive awareness. Changes in outcomes across time were assessed using multilevel mixed effects linear regression. RESULTS:Substance use improved significantly for MABT vs. TAU at 6 months and 12 months. Positive longitudinal effects on secondary outcomes for MABT were evident on respiratory sinus arrhythmia (RSA), a physiological index of emotion regulation; on craving; and on interoceptive awareness skills. Analyses based on participants who completed >75% of the intervention sessions revealed additional immediate significant improvements for MABT vs. TAU and WHE on depressive symptoms and emotion regulation difficulties and longitudinal improvement on mindfulness skills. CONCLUSIONS:Results show MABT to be efficacious for longitudinal health outcomes to support women's recovery as an adjunct to community-based SUD treatment.