Chronic Pain Clinical Trial
— ACTIONOfficial title:
Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | National Institute on Drug Abuse (NIDA) |
United States,
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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