Stepped Care for Patients to Optimize Whole Recovery (SC-POWR): An Effectiveness Trial Evaluating a Stepped Care Model for Individuals With Opioid Use Disorder and Chronic Pain.

Many patients who receive treatment for opioid use disorder (OUD) report experiencing chronic pain (CP), which is associated with high levels of ongoing nonmedical opioid use and low retention in OUD treatment. In pilot studies of patients with OUD receiving buprenorphine or methadone who had CP, cognitive behavioral therapy (CBT) attenuated nonmedical opioid use compared with treatment-as-usual (TAU), but patients in both treatment arms exhibited similar pain improvements. Adding exercise and stress reduction to this model may augment pain-related outcomes. With funding from National Institutes of Health, we plan to conduct a randomized clinical trial of 316 patients with OUD and CP to test the effectiveness of TAU compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce nonmedical opioid use and pain (primary outcomes) (Aim 1) and decrease pain intensity and interference, alcohol use, anxiety, depression and stress, and improve sleep (secondary outcomes) (Aim 2). Eligible participants will be randomized to receive TAU (buprenorphine or methadone and at least once a month individual or group counseling) or SC-POWR (ie, TAU and up to 12 CBT sessions) for 24 weeks. Based on prespecified nonresponse criteria, SC-POWR may be stepped up at week 6 to receive onsite weekly group sessions of exercise (Wii Fit, Tai Chi) and "stepped up" again at week 15 to receive weekly group sessions of stress reduction (relaxation training, auricular acupuncture). They will be followed for another 24 weeks to evaluate durability of treatment response for illicit opioid use, alcohol use, pain, anxiety, depression, stress, sleep, and retention in medications for OUD (Aim 3).

Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial.

BACKGROUND: At-risk levels of alcohol use threaten the health of patients with HIV (PWH), yet evidence-based strategies to decrease alcohol use and improve HIV-related outcomes in this population are lacking. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among PWH and at-risk alcohol use. METHODS: In this multi-site, randomized trial conducted between January 28, 2013 through July 14, 2017, we enrolled PWH and at-risk alcohol use [defined as alcohol consumption of ≥ 14 drinks per week or ≥ 4 drinks per occasion in men ≤ 65 years old or ≥ 7 drinks per week or ≥ 3 drinks per occasion in women or men > 65 years old]. ISAT (n = 46) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 47) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat principles. RESULTS: Despite a multi-pronged approach, we only recruited 37% of the target population (n = 93/254). Among ISAT participants, 50% advanced to Step 2, among whom 57% advanced to Step 3. Participants randomized to ISAT and TAU had no observed difference in drinks per week over the past 30 days at week 24 (primary outcome) [least square means (Ls mean) (95% CI) = 8.8 vs. 10.6; adjusted mean difference (AMD) (95% CI) = - 0.4 (- 3.9, 3.0)]. CONCLUSION: An insufficient number of patients were interested in participating in the trial. Efforts to enhance motivation of PWH with at-risk alcohol use to engage in alcohol-related research and build upon ISAT are needed. Trial registration Clinicaltrials.gov: NCT01410123, First posted August 4, 2011.

Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial.

BACKGROUND: There is no known safe level of alcohol use among patients with HIV and liver disease. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use, HIV, and liver outcomes among patients with HIV and liver disease. METHODS: In this multi-site, randomized trial conducted between January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score > 1.45]. ISAT (n = 49) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 46) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat. RESULTS: Among ISAT participants, 55% advanced to Step 2, among whom 70% advanced to Step 3. Participants randomized to ISAT and TAU increased abstinence (primary outcome) over time. Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24. VACS Index scores (AMD [95% CI] = 1.1 [-3.2, 5.5]) and the proportion with an undetectable HIV viral load (AOR [95% CI] = 0.3 [0.1, 1.3]) did not differ by group at week 24 (p values >0.05). ISAT had non-significantly lower FIB-4 scores (adjusted mean difference [AMD] [95% CI] = -0.2 [-0.9, 0.5]), ALT (AMD [95% CI] = -7 [-20, 7]) and AST (AMD [95% CI] = -4 [-15, 7]) at week 24 compared to TAU. CONCLUSION: ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers among patients with HIV and liver disease.

The feasibility and acceptability of groups for pain management in methadone maintenance treatment.

OBJECTIVES: Effective and safe pain management interventions in methadone maintenance treatment are needed. METHODS: We examined the feasibility (ie, single-session attendance) and acceptability (ie, patient satisfaction and booster session attendance) of cognitive-behavioral therapy-informed groups for pain management-Coping With Pain, Relaxation Training, Group Singing, and Mindful Walking. Pre- and postsession measures were collected. RESULTS: A total of 349 (out of a census of approximately 800) methadone-maintained patients attended at least 1 of the groups. Group satisfaction was high. Booster session attendance was numerically lower in Mindful Walking (14%) than in the other groups (at least 40%). Repeat attendance at Coping With Pain was associated with reduced characteristic pain intensity and depression, whereas repeat attendance at Relaxation Training was associated with decreased anxiety. CONCLUSIONS: Coping With Pain, Relaxation Training, and Group Singing are transportable, affordable, adaptable, and tolerated well by patients with pain and show promise as components of a multimodal pain management approach in methadone maintenance treatment.

Prevalence of mood and substance use disorders among patients seeking primary care office-based buprenorphine/naloxone treatment.

BACKGROUND: Psychiatric comorbidity can adversely affect opioid dependence treatment outcomes. While the prevalence of psychiatric comorbidity among patients seeking methadone maintenance treatment has been documented, the extent to which these findings extend to patients seeking primary care office-based buprenorphine/naloxone treatment is unclear. AIMS: To determine the prevalence of mood and substance use disorders among patients seeking primary care office-based buprenorphine/naloxone treatment, via cross sectional survey. METHODS: 237 consecutive patients seeking primary care office-based buprenorphine/naloxone treatment were evaluated using modules from the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). Current (past 30 days) and past diagnoses were cataloged separately. RESULTS: Patients ranged in age from 18 to 62 years old (M=33.9, SD=9.9); 173 (73%) were men; 197 (83%) were white. Major depression was the most prevalent mood disorder (19% current, 24% past). A minority of patients met criteria for current dysthymia (6%), past mania (1%), or past hypomania (2%). While 37 patients (16%) met criteria for current abuse of or dependence on at least one non-opioid substance (7% cocaine, 4% alcohol, 4% cannabis, 2% sedatives, 0.4% stimulants, 0.4% polydrug), 168 patients (70%) percent met criteria for past abuse of or dependence on at least one non-opioid substance (43% alcohol, 38% cannabis, 30% cocaine, 9% sedatives, 8% hallucinogens, 4% stimulants, 1% polydrug, and 0.4% other substances). CONCLUSION: Mood and substance use comorbidity is prevalent among patients seeking primary care office-based buprenorphine/naloxone treatment. The findings support the need for clinicians to assess and address these conditions.

Use of conventional, complementary, and alternative treatments for pain among individuals seeking primary care treatment with buprenorphine-naloxone.

UNLABELLED: Previous studies have not examined patterns of pain treatment use among patients seeking office-based buprenorphine-naloxone treatment (BNT) for opioid dependence. OBJECTIVES: To examine, among individuals with pain seeking BNT for opioid dependence, the use of pain treatment modalities, perceived efficacy of prior pain treatment, and interest in pursuing pain treatment while in BNT. METHODS: A total of 244 patients seeking office-based BNT for opioid dependence completed measures of demographics, pain status (ie, "chronic pain (CP)" [pain lasting at least 3 months] vs "some pain (SP)" [pain in the past week not meeting the duration criteria for chronic pain]), pain treatment use, perceived efficacy of prior pain treatment, and interest in receiving pain treatment while in BNT. RESULTS: In comparison with the SP group (N = 87), the CP group (N = 88) was more likely to report past-week medical use of opioid medication (adjusted odds ratio [AOR] = 3.2; 95% CI, 1.2-8.4), lifetime medical use of nonopioid prescribed medication (AOR = 2.2; 95% CI, 1.1-4.7), and lifetime use of prayer (AOR = 2.8; 95% CI, 1.2-6.5) and was less likely to report lifetime use of yoga (AOR = 0.2; 95% CI, 0.1-0.7) to treat pain. Although the 2 pain groups did not differ on levels of perceived efficacy of prior lifetime pain treatments, in comparison with the SP group, the CP group was more likely to report interest in receiving pain treatment while in BNT (P < 0.001). CONCLUSIONS: Individuals with pain seeking BNT for opioid dependence report a wide range of conventional, complementary, and alternative pain-related treatments and are interested (especially those with CP) in receiving pain management services along with BNT.

Group-based strategies for stress reduction in methadone maintenance treatment: what do patients want?

OBJECTIVES: To assess methadone maintenance treatment (MMT) patients' willingness to use, and perceived efficacy of, conventional and unconventional group stress reduction treatments. METHODS: A survey, developed by the authors, was administered to 150 MMT patients. RESULTS: Levels of treatment willingness and perceived efficacy for both conventional and unconventional treatments were relatively high; however, ratings for conventional interventions were, on average, significantly higher than those for unconventional ones. The highest rated conventional and unconventional treatments in terms of willingness and perceived efficacy were nutrition and spiritual counseling, respectively, whereas the lowest rated conventional and unconventional group treatments were anger management and visualization training, respectively. White race was a significant predictor of lower willingness to try conventional and unconventional group therapies and lower perceived efficacy of unconventional group treatment, whereas female sex and older age were significant predictors of higher levels of willingness to try unconventional group treatment. Higher levels of substance use problems were associated with increased willingness to try conventional group treatment. Higher levels of anxiety emerged as a significant independent predictor of treatment willingness and perceived efficacy for both conventional and unconventional group treatments. CONCLUSIONS: The relatively high levels of treatment willingness and perceived efficacy of conventional and unconventional group stress reduction treatments point to the feasibility of offering these interventions in MMT and suggest that, in particular, high levels of anxiety are associated with greater treatment willingness and perceived treatment efficacy.

Conventional and unconventional treatments for stress among methadone-maintained patients: treatment willingness and perceived efficacy.

We surveyed 150 methadone maintenance treatment (MMT) program patients about willingness to use, and perceived efficacy of, conventional and unconventional nonpharmacological stress-related treatments. Although levels of treatment willingness and perceived efficacy for both conventional and unconventional treatments were high, ratings for conventional interventions were, on average, significantly higher than those for unconventional ones. Dimensions of psychiatric distress-but not demographic or MMT characteristics-predicted treatment willingness for conventional therapies and treatment willingness and perceived efficacy for unconventional therapies. These findings are likely to have implications for resource and program planning in MMT programs.

Conventional and nonconventional pain treatment utilization among opioid dependent individuals with pain seeking methadone maintenance treatment: a needs assessment study.

OBJECTIVE AND METHODS: We surveyed 293 individuals seeking methadone maintenance treatment (MMT) for opioid dependence about pain, pain treatment utilization, perceived efficacy of prior pain treatment, and interest in pursuing pain treatment while in MMT. RESULTS: Among the 213 respondents reporting recent pain of at least moderate typical pain intensity, those with and those without a lifetime history of chronic pain endorsed similar rates of conventional (with the exception of past-week medical use of nonopiate medication), complementary, and alternative medicine utilization for pain reduction and a numerically smaller proportion endorsed last-week utilization of complementary and alternative medicine when compared with conventional medicine. The most frequently endorsed lifetime conventional pain treatments included opiate and over-the-counter medications, whereas the most frequently endorsed lifetime complementary and alternative medicine pain treatments included stretching, physical exercise, physical therapy, heat therapy, and prayer. Perceived efficacy of prior pain treatment but not interest in pain treatment was associated with chronic pain history status. CONCLUSION: These findings may have implications for resource and program planning in MMT programs.

Allopathic, complementary, and alternative medical treatment utilization for pain among methadone-maintained patients.

We surveyed 150 methadone maintenance treatment program (MMTP) patients about pain, pain treatment utilization, perceived efficacy of prior pain treatment, and interest in pursuing pain treatment at the MMTP. Respondents with chronic severe pain (CSP) (ie, pain lasting at least six months with moderate to severe pain intensity or significant pain interference) and "some pain" (ie, pain reported in the previous week but not CSP) endorsed similar rates of past-week and lifetime allopathic or standard medical (with the exception of lifetime medical use of non-opiate medication) and complementary and alternative medicine (CAM) utilization for pain reduction. Prior pain treatments were perceived to be less effective by CSP than SP patients but both groups had equivalent high rates of interest in pain treatment associated with the MMTP. These findings may have implications for resource and program planning in MMTPs.