Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT.

BACKGROUND: Office-based opioid treatment with buprenorphine has emerged as a popular evidence-based treatment for opioid use disorder. Unfortunately, psychosocial stress, anxiety, pain, and co-morbid substance use increase patients' risk for relapse. We designed this study to compare the effects of complementing buprenorphine treatment with 24 weeks of a live-online Mindful Recovery Opioid Care Continuum (M-ROCC) group to a time and attention-matched, live-online Recovery Support Group (RSG) active control condition. METHODS: We plan to enroll a maximum of N = 280 and randomize at least N = 192 patients prescribed buprenorphine through referrals from office-based and telemedicine buprenorphine treatment providers and social media advertisements. Participants will be randomly assigned to M-ROCC or RSG and will be blinded to their treatment condition. The primary outcome for this study will be biochemically confirmed periods of abstinence from illicit opioids, as measured by self-reported use and randomly collected, video-observed oral fluid toxicology testing during the final 12 weeks of study participation. Secondary outcomes include changes in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and pain interference scores between baseline and week 24. RESULTS: The trial was funded by the National Institutes of Health, HEAL Initiative through NCCIH (R33AT010125). Data collection is projected to end by September 2023, and we expect publication of results in 2024. CONCLUSION: If the M-ROCC intervention is found to be effective in this format, it will demonstrate that live-online mindfulness groups can improve outcomes and address common co-morbidities like anxiety and pain during buprenorphine treatment.

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study.

BACKGROUND: A mindfulness-based intervention that reduces comorbid pain, anxiety, and substance use during office-based opioid treatment (OBOT) could enhance retention and prevent overdose. We conducted a pilot study of the Mindful Recovery OUD Care Continuum (M-ROCC), a 24-week trauma-informed program with a motivationally-sensitive curriculum. METHODS: Patients prescribed buprenorphine (N = 18) enrolled in M-ROCC. We collected urine toxicology biweekly. At 0, 4, and 24 weeks, participants completed PROMIS-Pain, PROMIS-Anxiety, Mindfulness (FFMQ), Experiential Avoidance (BEAQ), Interoceptive Awareness (MAIA), and Self-Compassion (SCS-SF) scales. We estimated changes over time using mixed models. Participants completed qualitative interviews at 4 and 24 weeks. RESULTS: Positive urine toxicology decreased over time for cocaine (ß = -.266, p = .008) and benzodiazepines (ß = -.208, p = .028). M-ROCC reduced PROMIS-Pain (Z = -2.29; p = .022), BEAQ (Z = -2.83; p = .0005), and increased FFMQ (Z = 3.51; p < .001), MAIA (Z = 3.40; p = .001), and SCS-SF (Z = 2.29; p = .022). Participants with co-morbid anxiety had decreased PROMIS-Anxiety (Z = -2.53; p = .012). Interviewed participants commonly used mindfulness practices for stress and anxiety (12/12, 100%), and to reduce pain catastrophizing and rumination (7/12, 58%). CONCLUSION AND SCIENTIFIC SIGNIFICANCE: This is the first study to report the effects of a 24-week mindfulness program during buprenorphine treatment on common comorbidities, including pain interference, anxiety, cocaine, and benzodiazepine use. The findings that M-ROCC is associated with reduced experiential avoidance, as well as increased interoceptive awareness and self-compassion, align with proposed mechanisms that are now extended to OUD treatment. Future larger randomized controlled trials are needed before effectiveness can be established and the role of these mechanisms can be confirmed.

Specific polysubstance use patterns predict relapse among patients entering opioid use disorder treatment.

Introduction: While polysubstance use has consistently been associated with higher rates of relapse, few studies have examined subgroups with specific combinations and time course of polysubstance use (i.e., polysubstance use patterns). This study aimed to classify and compare polysubstance use patterns, and their associations with relapse to regular opioid use in 2637 participants in three large opioid use disorder (OUD) treatment trials. Methods: We explored the daily patterns of self-reported substance use in the 28 days prior to treatment entry. Market basket analysis (MBA) and repeated measure latent class analysis (RMLCA) were used to examine the subgroups of polysubstance use patterns, and multiple logistic regression was used to examine associations between identified classes and relapse. Results: MBA and RMLCA identified 34 "associations rules " and 6 classes, respectively. Specific combinations of polysubstance use and time course (high baseline use and rapid decrease of use prior to initiation) predicts a worse relapse outcome. MBA showed individuals who co-used cocaine, heroin, prescription opioids, and cannabis had a higher risk for relapse (OR = 2.82, 95%CI = 1.13, 7.03). In RMLCA, higher risk of relapse was observed in individuals who presented with high baseline prescription opioid (OR = 1.9, 95% CI = 1.3, 2.76) or heroin use (OR = 3.54, 95%CI = 1.86, 6.72), although use decreased in both cases prior to treatment initiation. Conclusions: Our analyses identified subgroups with distinct patterns of polysubstance use. Different patterns of polysubstance use differentially predict relapse outcomes. Interventions tailored to these individuals with specific polysubstance use patterns prior to treatment initiation may increase the effectiveness of relapse prevention.

Cannabinoids for the Treatment of Opioid Use Disorder: Where is the Evidence?

With the growing public interest in the potential therapeutic benefits of cannabis and cannabinoids in the treatment of opioid use disorder (OUD), some states have now either added or proposed to add OUD as an indication for their state's medical marijuana program. However, these initiatives are based on weak evidence which at present do not support the listing of cannabis or cannabinoids as a treatment for OUD. Nevertheless, studying the potential therapeutic applications of carefully chosen components of cannabis or cannabinoids to treat specific aspects of OUD is not without scientific merit. Given the high rates of treatment discontinuation among those taking medications for OUD, interventions that further improve clinical outcomes are especially needed. The potential therapeutic applications of cannabis and cannabinoids in the treatment of OUD are worthy of further study, but it should be conducted with the same rigor that we expect of all pharmaceutical products. Until we have more research to show their efficacy, policy makers and clinicians should refrain from portraying cannabis and cannabinoids as evidence-based treatments for OUD.

Religious coping in patients with severe substance use disorders receiving acute inpatient detoxification.

BACKGROUND AND OBJECTIVES: Religious coping, one of the most widely studied components of spirituality among psychiatric populations, has rarely been addressed in patients with severe substance use disorders (SUD). The aim of our study was to elucidate whether religious coping is related to symptom expression and mutual-help participation. METHODS: Self-reported religious coping was assessed in individuals sequentially admitted to a private psychiatric hospital for inpatient detoxification. Target symptoms of SUD included severity of substance use prior to admission and craving during detoxification. Three hundred thirty-one patients (68.6% male) participated in the survey; mean age was 38.0 years, and primary presenting diagnosis was most commonly alcohol use disorder (n = 202; 61%), followed by opioid use disorder (n = 119; 36%). RESULTS: Positive religious coping was associated with significantly greater mutual-help participation, fewer days of drug use prior to admission, and was modestly, yet significantly associated with lower drug craving. Negative religious coping was associated with lower confidence in the ability to remain abstinent post-discharge and higher drug craving. CONCLUSIONS: Consistent with hypotheses, greater positive religious coping was associated with greater mutual-help participation, lower severity of pre-admission drug use, and lower substance craving during detoxification. Use of positive religious coping may modify the course of SUD recovery by promoting engagement in mutual-help activities. SCIENTIFIC SIGNIFICANCE: The findings of this study suggest that positive and negative religious coping are linked with several key SUD recovery variables. Further research to replicate this finding and to assess mechanisms within this potential association is warranted. (Am J Addict 2017;26:744-750).

Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders.

Cognitive behavioral therapy and the nicotine transdermal patch for dual nicotine and cannabis dependence: a pilot study.

BACKGROUND AND OBJECTIVES: We assessed the feasibility of a new cognitive behavioral therapy (CBT) manual, plus transdermal patch nicotine replacement therapy (NRT), to treat co-occurring nicotine and cannabis dependence. METHOD: Seven of 12 (58.3%) adults with DSM-IV diagnoses of both nicotine and cannabis dependence completed 10 weeks of individual CBT and NRT. RESULTS: Participants smoked 12.6 ± 4.9 tobacco cigarettes per day at baseline, which was reduced to 2.1 ± 4.2 at the end of treatment (F[5] = 23.5, p < .0001). The reduction in cannabis use from 10.0 ± 5.3 inhalations per day at baseline to 8.0 ± 5.3 inhalations per day at 10 weeks was not significant (F[5] = 1.12, p = .37). There was a significant decrease from the mean baseline Fagerstrom Test for Nicotine Dependence scores at weeks 4, 6, 8, and 10 of treatment (F[4] = 19.8, p < .001) and mean Client Satisfaction Questionnaire scores were uniformly high (30.6 ± 1.9). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: A CBT plus NRT treatment program significantly reduced tobacco smoking but did not significantly reduce cannabis use in individuals with co-occurring nicotine and cannabis dependence. There was no compensatory increase in cannabis use following the reduction in tobacco smoking, suggesting that clinicians can safely pursue simultaneous treatment of co-occurring nicotine and cannabis dependence. The intervention was well-liked by the 7 of the 12 enrollees who completed the study.

Adaptation of the patient feedback survey at a community treatment setting.

The Patient Feedback Survey is a performance improvement measure designed to assess the quality of outpatient substance abuse treatment. We modified and administered this measure to 500 individuals at a multisite treatment provider. Although the feedback scores were high in general, analyses of variance showed score variability in relation to type and length of treatment. Moreover, respondents who reported any use of marijuana, cravings for substances, or mutual-support group attendance (ie, Alcoholics Anonymous or Narcotics Anonymous) had lower feedback scores than respondents without these experiences. We highlight the importance of investigating treatment evaluations in the context of other recovery experiences.

Predictors of buprenorphine-naloxone dosing in a 12-week treatment trial for opioid-dependent youth: secondary analyses from a NIDA Clinical Trials Network study.

INTRODUCTION: The present investigation examines baseline patient characteristics to predict dosing of buprenorphine-naloxone, a promising treatment for opioid addiction in youths. METHODS: This study of 69 opioid-dependent youths is a secondary analysis of data collected during a National Institute on Drug Abuse (NIDA) Clinical Trials Network study. Outpatients aged 15-21 were randomized to a 12-week buprenorphine-naloxone dosing condition (including 4 weeks of taper). Predictors of dosing included sociodemographic characteristics (gender, race, age, and education), substance use (alcohol, cannabis, cocaine, and nicotine use), and clinical characteristics (pain and withdrawal severity). RESULTS: Most (75.4%) reported having either "some" (n=40, 58.0%) or "extreme" (n=12, 17.4%) pain on enrollment. Maximum daily dose of buprenorphine-naloxone (19.7 mg) received by patients reporting "extreme" pain at baseline was significantly higher than the dose received by patients reporting "some" pain (15.0mg) and those without pain (12.8 mg). In the adjusted analysis, only severity of pain and withdrawal significantly predicted dose. During the dosing period, there were no significant differences in opioid use, as measured by urinalysis, by level of pain. CONCLUSION: These data suggest that the presence of pain predicts buprenorphine-naloxone dose levels in opioid-dependent youth, and that patients with pain have comparable opioid use outcomes to those without pain, but require higher buprenorphine-naloxone doses.

A randomized trial of transcutaneous electric acupoint stimulation as adjunctive treatment for opioid detoxification.

This pilot study tested the effectiveness of transcutaneous electric acupoint stimulation (TEAS) as an adjunctive treatment for inpatients receiving opioid detoxification with buprenorphine-naloxone at a private psychiatric hospital. Participants (N = 48) were randomly assigned to active or sham TEAS and received three 30-minute treatments daily for 3 to 4 days. In active TEAS, current was set to maximal tolerable intensity (8-15 mA); in sham TEAS, it was set to 1 mA. By 2 weeks postdischarge, participants in active TEAS were less likely to have used any drugs (35% vs. 77%, p < .05). They also reported greater improvements in pain interference (F = 4.52, p < .05) and physical health (F = 4.84, p < .01) over time. TEAS is an acceptable, inexpensive adjunctive treatment that is feasible to implement on an inpatient unit and may be a beneficial adjunct to pharmacological treatments for opioid detoxification.

HIV risk behavior in opioid dependent adults seeking detoxification treatment: an exploratory comparison of heroin and oxycodone users.

Heroin users are at high risk for HIV infection, but little is known about HIV risk in oxycodone users. This study examined HIV risk behaviors in heroin (n = 27) and oxycodone (n = 23) users seeking inpatient detoxification at a private psychiatric hospital. Drug use histories were similar, except oxycodone users used marijuana more frequently. Injection drug risk occurred exclusively among heroin users. The rates of sexual activity (66%), unprotected intercourse (69%), sex while intoxicated (74%), and sex with strangers (24%) were similar, but more oxycodone users had multiple partners (39% vs. 6%, p < .05). HIV prevention efforts should target both heroin and oxycodone users.

Additional treatment services in a cocaine treatment study: level of services obtained and impact on outcome.

The objective of this study was to examine the level of additional treatment services obtained by patients enrolled in the NIDA Cocaine Collaborative Study, a multi-center efficacy trial of four treatments for cocaine dependence, and to determine whether these services impact treatment outcome. Cocaine-dependent patients (N = 487) were recruited at five sites and randomly assigned to six months of one of four psychosocial treatments. Assessments were made at baseline, monthly during treatment, and at follow-ups at 9, 12, 15, and 18 months post-randomization. On average, patients received little or no additional treatment services during active treatment (first six months), but the rate of obtaining most services increased during the follow-up phase (month 7 to 18). In general, the treatment groups did not differ in the rates of obtaining non-protocol services. For all treatment groups, patients with greater psychiatric severity received more medical and psychiatric services during active treatment and follow-up. Use of treatment services was unrelated to drug use outcomes during active treatment. However, during the follow-up period, increased use of psychiatric medication, twelve-step attendance, and twelve-step participation was related to less drug use. The results suggest that during uncontrolled follow-up phases, additional non-protocol services may potentially confound the interpretation of treatment group comparisons in drug use outcomes.