Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) accelerated rTMS over the left dorsolateral prefrontal cortex, by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at 4-, 12-, 24- and 52-week follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age ≥ 18yrs;

• English-speaking;

• On LTOT, defined as taking daily prescription opioid therapy for 90 days or more;

• Past week average morphine equivalent dose (MED) ≥50;

• Willing and able to complete written informed consent;

• Willing and able to use a mobile/cell phone;

• Have at least one additional risk for opioid toxicity or overdose from the following list:

• Taking benzodiazepines with opioids

• Substance Use Disorder diagnosis \[non-tobacco; Opioid Risk Tool\]

• Having ever experienced an overdose

• Current major medical problem \[e.g. mod-severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue in the past 6 months\]

• Response to Brief Pain Iinventory Item 8 \<30%, suggesting less than moderately clinically meaningful response to pain treatment

• Co-morbid psychiatric diagnosis \[Opioid Risk Tool\]

• Signs of opioid misuse \[any score \>0 on the following COMM Items: 3, 4, 5, 9, 10, 11, 14, 15, 16\]

• Opioid Risk Tool \>3 or Current Opioid Misuse Measure ≥ 9

• Struggling with the following side effects from opioids \[self-report\]: Dizziness and/or falls Difficult-to-manage stomach pain, nausea, constipation or GI issues, Fatigue or low energy, Sleepiness or sedation, Trouble with memory or thinking clearly \[COMM Item 1\>0\], Other troublesome side effect \[open answer\]

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Kelly Barth
stephen@musc.edu
843-792-0686
Backup
Rafael Mendoza
mendozra@musc.edu
Time Frame
Start Date: 2024-08-12
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 240
Treatments
Experimental: open label BUP
Active_comparator: Real vs Placebo BUP
Active_comparator: Real vs Sham TMS
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov