Health TrialsbyHealthPanel

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

ConditionsOpioid WithdrawalChronic Pain
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Taking benzodiazepines with opioids

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

Dizziness and/or falls

Difficult-to-manage stomach pain, nausea, constipation or GI issues

Disqualifiers

. Those with nicotine use disorder.

. Those meeting criteria for prescription opioid use disorder using only prescribed opioids will be considered on a case-by-case basis.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Buprenorphine Patch

    Drug

    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

  • Placebo

    Drug

    double-blinded randomization to placebo or transdermal buprenorphine

  • Transcranial Magnetic Stimulation (TMS)

    Device

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

  • Sham Transcranial Magnetic Stimulation (TMS)

    Device

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

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: open label BUPExperimental treatment 1 intervention
Group B: Real vs Placebo BUPActive comparator 2 interventions
Group C: Real vs Sham TMSActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Buprenorphine Tolerability

Tolerability of open-label transdermal buprenorphine. Buprenorphine tolerability defined as the proportion of patients who do not discontinue buprenorphine due to adverse effects or intolerance.

Time frame
up to Day-13
2

Pain Severity -with Buprenorphine Patch

Pain severity is measured by the Brief Pain Inventory (BPI) Severity Scale and is typically scored as the mean of the four severity items ("average," "worst," "usual," "now," range 0-10) with a higher score being worse.

Time frame
up to Day-20

Secondary outcomes

1

Buprenorphine Transition Rate

Buprenorphine transition rate defined as the proportion of participants who spontaneously elect to continue buprenorphine after Phase I.

Time frame
Day-20
2

Quality of Life -with Buprenorphine Patch

Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) score summarizes multiple domains into a single score anchored at 0 (as bad as dead) and 1 (perfect or ideal health). This score quantifies the value that individuals place on different states of health. PROPr is calculated from the scores for the 7 PROMIS domains: Cognition, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities.

Time frame
up to Day-20

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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