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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06442566
Other study ID # Pro00130123
Secondary ID 1R01DA058620
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 2024
Est. completion date March 31, 2029

Study information

Verified date May 2024
Source Medical University of South Carolina
Contact Kelly Barth
Phone 843-792-0686
Email stephen@musc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

With little evidence available to guide the provision of clinical care for patients on long-term opioid therapy (LTOT) in whom the risks outweigh the benefits, major questions remain about optimizing the risk/benefit profile of LTOT, including: how to best engage patients voluntarily in this process; the safety, tolerability and effectiveness of newer treatment approaches; and optimal treatment selection. The primary objective of the proposed study is to begin to systematically address gaps in this important area to improve pain, reduce risk, and improve quality of life for individuals on LTOT.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 240
Est. completion date March 31, 2029
Est. primary completion date March 31, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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] Exclusion Criteria: - Known seizure disorder; - On anti-convulsant medication; - Known allergy to buprenorphine; - Active moderate or severe non-opioid substance use disorder (DSMV criteria); - Active suicidal Ideation; - Known bipolar disorder; - Cognitive disorder limiting ability to consent or fully participate in the BCI intervention; - Severe medical condition (e.g. malignancy), likely to limit life expectancy or study participation; - Receiving methadone or buprenorphine treatment for OUD or pain; - On naltrexone; - Pregnancy; - Currently Incarcerated; - Hypokalemia; - Clinically unstable cardiac or pulmonary disease; - Taking medications that prolong QTc interval or personal/immediate family history of Long QT Syndrome.

Study Design


Related Conditions & MeSH terms


Intervention

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
Placebo
double-blinded randomization to placebo or transdermal buprenorphine
Device:
Transcranial Magnetic Stimulation (TMS)
double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS
Sham Transcranial Magnetic Stimulation (TMS)
double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to Day-13
Primary 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. up to Day-20
Secondary Buprenorphine Transition Rate Buprenorphine transition rate defined as the proportion of participants who spontaneously elect to continue buprenorphine after Phase I. Day-20
Secondary 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.
up to Day-20
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