Clinical trial NCT06543355: The Acupuncture for Pain, Opioid Use Disorder and Mood
Official title: The Acupuncture for Pain, Opioid Use Disorder and Mood (AcuPOM) Study: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Opioid Use Disorder
Mood Change
Opioid Misuse
Opioid-Related Disorders
Keywords: Acupuncture
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Acupuncture
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to determine how patients with chronic pain and opioid use disorder will respond to treatment with acupuncture, including whether there will be any changes in mood. Results from this study have the potential to inform future studies in patients who would consider using acupuncture as an intervention for their conditions.

Detailed description: In this 4-week pilot study, the feasibility of recruiting a sample of participants in a modified Battlefield Acupuncture + National Acupuncture Detoxification Association (BFA + NADA) protocol will be assessed. Utilizing a novel BFA (Battlefield Acupuncture) plus a NADA (National Acupuncture Detoxification Association) protocol, approximately 20 participants with chronic pain and Opioid Use Disorder (OUD), receiving Methadone through an Opioid Treatment Program (OTP) at Montefiore Medical Center, will be recruited. Each participant will receive a modified BFA + NADA treatment, twice per week over 4 weeks for a total of 8 treatments at the clinic. All participants will also have the small seeds placed to facilitate at-home acupressure treatment. In this feasibility study, the investigator team will collect feasibility data from each participant at every session over the course of 4 weeks. Feasibility outcomes are defined in the Outcome Measures of this registration. As part of the study, the following will also be monitored to explore preliminary efficacy: (1) pain intensity and physical functioning, (2) opioid cravings and substance use, and (3) mood, insomnia, and stress. The research team will conduct surveys assessing pain, physical functions, the changes in stress, mood, insomnia and psychological changes at baseline, and before and after every treatment.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old,
2. English proficiency;
3. receiving methadone treatment at an OTP through the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability;
4. chronic pain of at least moderate pain severity (score of at least 4 on the Pain, Enjoyment of Life and General Activity (PEG) scale);
5. willingness to participate in all study components; and
6. ability to provide informed consent

Exclusion Criteria:

1. Have pending surgery or invasive pain management procedure;
2. Have a pending or planned relocation;
3. have an acutely or exacerbation of psychotic, suicidal, or homicidal conditions that preclude the ability to participate; and
4. pregnancy

Primary outcomes:
measure: Feasibility - Percentage Consented
timeFrame: During the informed consent process, prior to the intervention
measure: Feasibility - Percentage Retained
timeFrame: Upon completion of the study, up to four weeks
measure: Adherence to acupuncture treatments
timeFrame: At 0, 2, and 4 week study visits, up to four weeks total
measure: Acceptability/Satisfaction
timeFrame: Upon completion of the study, up to four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Division of Substance Abuse (DoSA) Wellness Center at Melrose
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Jessica Bayner, MD
role: PRINCIPAL_INVESTIGATOR
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