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An Effective and Safe Novel Treatment of Opioid Use Disorder: Unilateral Transcranial Photobiomodulation.

ABSTRACT: Background: The opioid epidemic is a global tragedy even with current treatments, and a novel, safe, and effective treatment would be welcomed. We report here our findings from our second randomized controlled trial to evaluate unilateral transcranial photobiomodulation as a treatment for opioid use disorder. Methods: We enrolled 39 participants with active opioid cravings at 2 sites, 19 received the active treatment which consisted of a 4-min twice weekly (every 3 or 4 days) application of a light-emitting diode at 810 nm with an irradiance of 250 mW/cm² and a fluence of 60 J/cm² to the forehead over either the left or right dorsolateral prefrontal cortex with a fluence to the brain of 2.1 J/cm². Twenty participants received a sham treatment with the same device with foil over the bulb. The side of the treatment was based on Dual-Brain Psychology, which posits that one hemisphere is more affected by past maltreatments and is more prone to anxiety and drug cravings that the other hemisphere. We treated the hemisphere with the more positive hemispheric emotional valence (HEV) by 2 tests for HEV. Results: Our primary outcome was changes in pre-treatment opioid craving scale (OCS) minus baseline, and we found using a mixed model that the active group had a highly significant treatment ^* time benefit over the sham group, p < 0.0001, effect size at the last follow-up of 1.5. The active treatment benefited those not on buprenorphine as well as those not on it. The TimeLine Follow Back measure of opioid use was significantly better in the actively treated group, p = 0.0001, with an effect size of 0.45. We observed no adverse effects. Conclusion: Active unilateral transcranial photobiomodulation to the brain hemisphere with the better HEV was better than sham in the reduction of opioid cravings and opioid use to a very significant degree in a RCT of 39 participants at 2 independent sites. In the active group those on buprenorphine and those not on it both had improvements in cravings over the study. No adverse responses were reported in either group. ClinicalTrials.gov Identifier: NCT04340622.

SUBMITTER: Schiffer F

PROVIDER: S-EPMC8382852 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundOpioid use disorders (OUDs) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. We have developed a novel treatment that combines unilateral transcranial photobiomodulation (t-PBM) to the hemisphere with a more positive valence by Dual Brain Psychology (DBP).MethodsWe used a randomized, double blind, placebo-controlled protocol in which 22 patients with significant opioid cravings and a history of recent or current OUD attended three 1-h weekly sessions. After baseline measures of opioid craving and other psychometrics, subjects received two unilateral t-PBM applications (810 nm CW LED, 250 mW/cm2, 60 J/cm2, 4 min) or a sham (foil-covered LED) at F3 or F4. Prior to any treatment we used two tests to determine which hemisphere was more associated with a negative outlook and cravings and treated that side before the more positive hemisphere. Primary outcome measure was an opioid craving scale (OCS). Secondary outcomes were weekly Hamilton Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments and at follow-up.ResultsImmediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071. The effect size for the differences between active and sham was 0.73. For the active treatment from before and after treatment the effect size was 1.51 and for the sham, 0.45. The HDRS improved from a baseline of 15.1 to 8.8 (SD 10.3) a week after the active treatment and to 13.3 (SD 12.9) after the sham (p = 0.0071). HARS improved from 14.7 to 8.0 (SD 13.2) after the active treatments and to 14.3 (SD 16.0) after the sham, p = 0.08. Active treatment of the positive hemisphere after the negative hemisphere significantly improved the OCS, but there was no significant difference after the sham treatment. One patient complained of 2 h of abdominal bloating and dropped out; no other adverse effects were observed.DiscussionUnilateral t-PBM to the hemisphere with a more positive hemispheric emotional valence was an effective and safe treatment for opioid cravings as well as for depression and anxiety. Our results also lend support to the underlying premises of DBP.

Project description:BackgroundTraining future clinicians in safe opioid prescribing (SOP) and treatment of opioid use disorder (OUD) is critical to address the opioid epidemic. The Accreditation Council on Graduate Medical Education requires all programs to provide instruction and experience in pain management and will mandate addiction medicine clinical experiences for internal medicine trainees.ObjectiveAssess residents' training in SOP and treatment of OUD and identify training barriers.DesignCross-sectional nationally representative survey was emailed in 2019.ParticipantsFour hundred twenty-two Association of Program Directors in Internal Medicine members in US internal medicine residency programs.Main measuresProgram opportunities and challenges to developing or implementing training in SOP, treatment of OUD, and buprenorphine waiver training, and perceived curricular effectiveness.Key resultsThe response rate was 69.4% (293/422). Most programs required didactics in SOP (94.2%) and treatment of OUD (71.7%). Few programs required clinical experiences including addiction medicine clinics (28/240, 11.7%), inpatient consult services (11/240, 4.6%), or offsite treatment rotations (8/240, 3.3%). Lack of trained faculty limited developing or implementing curricula (61.5%). Few respondents reported that their program was "very effective" in teaching SOP (80/285, 28.1%) or treatment of OUD (43/282, 15.3%). Some programs offered buprenorphine waiver training to residents (83/286, 29.0%) and faculty (94/286, 32.9%) with few mandating training (11.7% (28/240) and 5.4% (13/240) respectively). Only 60 of 19,466 (0.3%) residents completed buprenorphine waiver training. Primary care programs/tracks were more likely to offer waiver training to residents (odds ratio [OR], 3.07; 95% CI, 1.68-5.60; P < 0.001) and faculty (OR, 1.08; 95% CI, 1.01-3.22; P = 0.05).ConclusionsIn this nationally representative survey, few internal medicine residency programs provided clinical training in SOP and treatment of OUD, and training was not viewed as very effective. Lack of effective training may have adverse implications for patients, clinicians, and society.

Project description:BackgroundUnintended pregnancies are prevalent among women with opioid use disorder (OUD). The Sex and Female Empowerment (SAFE) project developed a social-cognitive, theory-driven intervention to increase acceptance of and adherence to contraceptive practices among women receiving medication for OUD (MOUD). This study evaluated the feasibility and acceptability of two SAFE interventions (Face-to-face and Computer-adapted) compared to usual care as well as their efficacy to improve contraception utilization.MethodsThis pilot randomized trial enrolled 90 heterosexual, non-pregnant, reproductive-age women receiving MOUD. Participants were randomized into either a: SAFE Face-to-face intervention, SAFE Computer-adapted intervention, or usual care (UC) condition (n = 30 each) and followed for 6 months. Outcome measures included intervention completion, intervention satisfaction, attendance at a contraception consultation appointment, and long-acting reversible contraceptive (LARC) method receipt. A generalized linear model was used for inferential testing and to estimate least squares means (predicted probabilities for binary outcomes) and their standard errors.ResultsCompared to the UC condition, both the SAFE Face-to-face and the SAFE Computer-adapted intervention had higher intervention completion [Means (Standard Errors) = 0.97 (.03) and 0.97 (.03), respectively, vs. 0.53 (.09); ps<.001], higher intervention satisfaction [Ms (SEs) = 3.7 (.11) and 3.8 (.11), respectively, vs. 3.1 (.11); ps<0.001), higher contraception consultation visit attendance [Ms(SEs) = 0.80 (.07) and 0.73 (.08) vs. 0.33 (.09); p < .001], and greater LARC receipt [Ms(SEs) = 0.77 (.08) and 0.73 (.08) vs. 0.23 (.08); p < .001).ConclusionsSAFE appears feasible and efficacious for supporting women in contraception decision-making. Integrating SAFE into women's comprehensive OUD treatment services holds promise to increase contraceptive decision-making and initiation of a chosen method.

Project description:Background: Post-stroke depression (PSD) affects up to 50% of stroke survivors, reducing quality of life, and increasing adverse outcomes. Conventional therapies to treat PSD may not be effective for some patients. Repetitive transcranial magnetic stimulation (rTMS) is well-established as an effective treatment for Major Depressive Disorder (MDD) and some small trials have shown that rTMS may be effective for chronic PSD; however, no trials have evaluated an accelerated rTMS protocol in a subacute stroke population. We hypothesized that an accelerated rTMS protocol will be a safe and viable option to treat PSD symptoms. Methods: Patients (N = 6) with radiographic evidence of ischemic stroke within the last 2 weeks to 6 months with Hamilton Depression Rating Scale (HAMD-17) scores >7 were recruited for an open label study using an accelerated rTMS protocol as follows: High-frequency (20-Hz) rTMS at 110% resting motor threshold (RMT) was applied to the left dorsolateral prefrontal cortex (DLPFC) during five sessions per day over four consecutive days for a total of 20 sessions. Safety assessment and adverse events were documented based on the patients' responses following each day of stimulation. Before and after the 4-days neurostimulation protocol, outcome measures were obtained for the HAMD, modified Rankin Scale (mRS), functional independence measures (FIM), and National Institutes of Health Stroke Scales (NIHSS). These same measures were obtained at 3-months follow up. Results: HAMD significantly decreased (Wilcoxon p = 0.03) from M = 15.5 (2.81)-4.17 (0.98) following rTMS, a difference which persisted at the 3-months follow-up (p = 0.03). No statistically significant difference in FIM, mRS, or NIHSS were observed. No significant adverse events related to the treatment were observed and patients tolerated the stimulation protocol well overall. Conclusions: This pilot study indicates that an accelerated rTMS protocol is a safe and viable option, and may be an effective alternative or adjunctive therapy for patients suffering from PSD. Future randomized, controlled studies are needed to confirm these preliminary findings. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04093843.

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An Effective and Safe Novel Treatment of Opioid Use Disorder: Unilateral Transcranial Photobiomodulation.

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