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

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · May 29, 2024

Keywords

ClinConnect Summary

The ACTION trial is researching new ways to help people who have been using opioids for chronic pain management. The study will look at three different methods: starting a low dose of buprenorphine (a medication that can help with pain and reduce withdrawal symptoms), a brief therapy called Cognitive Behavioral Intervention (CBI) focused on managing pain, and a technique called repetitive Transcranial Magnetic Stimulation (rTMS) that targets the brain to help with pain relief. The goal is to see if these treatments can improve outcomes for individuals who are at risk of opioid misuse or overdose.

To participate in this trial, individuals must be at least 18 years old, speak English, and have been on daily opioid therapy for at least 90 days. They should also have a significant average dose of opioids and face additional risks, like having a history of overdose or current medical problems. Participants can expect to have their pain and treatment progress checked at various times during the study, including at 4, 12, 24, and 52 weeks. It's important to note that some individuals won't be eligible, such as those with certain medical conditions or those currently pregnant. The study is actively recruiting participants, and it aims to provide valuable insights into safer pain management options.

Gender

ALL

Eligibility criteria

• 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.