ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

August 12, 2024

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2029

Conditions
Opioid WithdrawalChronic Pain
Interventions
DRUG

Buprenorphine Patch

Buprenorphine patch dosing will be individualized based on each participant's current morphine-equivalent dose (per package insert/recommendations; between 5mcg and 20mcg per hour). Dosage based on baseline MEQ (\<30 MEQ = 5mcg/hr patch, 30-80 MEQ =10-15mcg/hour patch; \>80 MEQ = 20mcg/hour patch), which will remain on for 7 days (Phase Ia Days 1-7), as tolerated

DRUG

Placebo

double-blinded randomization to placebo or transdermal buprenorphine

DEVICE

Transcranial Magnetic Stimulation (TMS)

double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS

DEVICE

Sham Transcranial Magnetic Stimulation (TMS)

double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS

Trial Locations (1)

29407

RECRUITING

Medical University of South Carolina, Charleston

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Medical University of South Carolina

OTHER