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.
Brief Title
The Acupuncture for Pain, Opioid Use Disorder and Mood
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Pain
Opioid Use Disorder
Mood Change
Opioid Misuse
Opioid-Related Disorders
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Keywords
Acupuncture
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06543355
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2024-15724
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The Acupuncture for Pain, Opioid Use Disorder and Mood (AcuPOM) Study: A Pilot Trial
Primary Outcomes
Outcome Description
The percentage of total participants screened who have been consented will be calculated and reported.
Outcome Measure
Feasibility - Percentage Consented
Outcome Time Frame
During the informed consent process, prior to the intervention
Outcome Description
The percentage of total participants consented who complete the study will be calculated and reported.
Outcome Measure
Feasibility - Percentage Retained
Outcome Time Frame
Upon completion of the study, up to four weeks
Outcome Description
Adherence to acupuncture treatments treatments will also be used to assess feasibility. Adherence the intervention will be defined as the percentage of participants who completed all scheduled acupuncture treatments. Adherence will be successful if participants attend at least 50% of acupuncture treatments.
Outcome Measure
Adherence to acupuncture treatments
Outcome Time Frame
At 0, 2, and 4 week study visits, up to four weeks total
Outcome Description
Acceptability of and Satisfaction with the intervention will be assessed using a single outcome measure, the Patient Global Impression of Change Scale. This scale consists of a single question asking the participant to rate acceptability/satisfaction of the intervention on a seven-point scale ranging from 1 (= very much better) to 7 ( = very much worse). Higher scores are associated with less favorable participant perceptions of the intervention. Group mean scores will be summarized.
Outcome Measure
Acceptability/Satisfaction
Outcome Time Frame
Upon completion of the study, up to four weeks
Secondary Ids
Secondary Id
4RM1DA055437-02
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jessica Bayner
Investigator Email
jbayner@montefiore.org