TY - JOUR
AU - J. A. Rosansky
AU - L. Howard
AU - H. Goodman
AU - K. Okst
AU - T. Fatkin
AU - A. K. Fredericksen
AU - R. Sokol
AU - P. Gardiner
AU - G. Parry
AU - B. L. Cook
AU - R. D. Weiss
AU - Z. D. Schuman-Olivier
A1 - 
AB - 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.
AD - Cambridge Health Alliance, Center for Mindfulness and Compassion, 350 Main Street, Suite 5126, Malden, MA 02148, United States of America; Harvard Medical School, Department of Psychiatry, 25 Shattuck St., Boston, MA 02115, United States of America.; Cambridge Health Alliance, Center for Mindfulness and Compassion, 350 Main Street, Suite 5126, Malden, MA 02148, United States of America.; Cambridge Health Alliance, Department of Family Medicine, 1493 Cambridge St., Cambridge, MA 02139, United States of America; Tufts University School of Medicine, Family Medicine Residency Training Program, 136 Harrison Ave., Boston, MA 02111, United States of America.; Cambridge Health Alliance, Center for Mindfulness and Compassion, 350 Main Street, Suite 5126, Malden, MA 02148, United States of America; Harvard Medical School, Department of Psychiatry, 25 Shattuck St., Boston, MA 02115, United States of America; Health Equity Research Lab, Cambridge Health Alliance, Cambridge, MA 02139, United States of America.; Harvard Medical School, Department of Psychiatry, 25 Shattuck St., Boston, MA 02115, United States of America; McLean Hospital, 115 Mill St., Belmont, MA 02478, United States of America.; Cambridge Health Alliance, Center for Mindfulness and Compassion, 350 Main Street, Suite 5126, Malden, MA 02148, United States of America; Harvard Medical School, Department of Psychiatry, 25 Shattuck St., Boston, MA 02115, United States of America. Electronic address: zschuman@cha.harvard.edu.
AN - 38135210
BT - Contemp Clin Trials
C5 - Opioids & Substance Use; Measures
DA - Feb
DO - 10.1016/j.cct.2023.107417
DP - NLM
ET - 20231220
JF - Contemp Clin Trials
LA - eng
N2 - 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.
PY - 2024
SN - 1551-7144
SP - 107417
ST - Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT
T1 - Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT
T2 - Contemp Clin Trials
TI - Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT
U1 - Opioids & Substance Use; Measures
U3 - 10.1016/j.cct.2023.107417
VL - 137
VO - 1551-7144
Y1 - 2024
ER -