- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06948890
Effect of Music on Cue Reactivity for Patients With Opioid Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Opioid use disorder (OUD) presents a significant public health challenge, characterized by a complex interplay of biological, psychological, and environmental factors. One critical aspect of this disorder is cue reactivity, the phenomenon whereby exposure to drug-related cues trigger cravings and reinforce behaviors to use drugs. This study aims to explore the role of music as a potential modulator of cue reactivity in patients with OUD.
Music, with its profound emotional and psychological effects, may offer a unique avenue for intervention. Previous research has demonstrated that music can influence mood, reduce anxiety, and enhance emotional regulation. Listening to music may also attenuate nociceptive processing and change thresholds of pain tolerance. By examining how specific musical stimuli interact with drug-related cues, the researchers hope to identify whether music can serve as an adjunctive strategy or an emotional anchor that diminishes cravings associated with opioid cues. This research seeks to contribute to the development of innovative therapeutic strategies aimed at reducing relapse rates and promoting recovery among individuals struggling with OUD.
Through a carefully designed mixed methods experimental framework, the researchers will assess the effects of different musical genres on cue-induced cravings. It is anticipated that the findings will provide valuable insights into the potential of music as a complementary tool in the treatment of opioid use disorder, paving the way for more holistic and effective recovery approaches.
Specific Aim 1: To determine the effect of music on cue-induced craving for individuals with opioid use disorder compared to a control condition (silence).
Hypothesis 1: Compared to the control condition, listening to music will attenuate cue-induced craving as assessed on a 100-point VAS craving scale.
Specific Aim 2: Identify the role of music in people's use of opioids through individual interviews with study participants.
Hypothesis 2: There will be key themes that emerge related to people's use of opioids as well as in their treatment and recovery.
This is a donor-funded, open label, pilot, proof-of-concept study with two parts. The study will aim to randomize N=28 individuals (14 in control arm and 14 in intervention arm) who have a history of opioid use disorder. Individuals will be recruited from a variety of means including online study recruitment and through fliers stationed at MGB-affiliated addiction clinics (including the Brigham and Women's Hospital and Massachusetts General Hospital Bridge Clinics, the Faulkner Addiction Recovery Program, and the MGH West End clinic).
Participants who agree to participate in the study will come to the Center for Clinical Investigation (CCI) once. The entirety of the study for each participant entails one CCI visit.
In the first phase, participants will answer a demographic questionnaire and a variety of psychological assessments. They will answer a question pertaining to their degree of opioid craving at that moment, on a 100-point visual analog scale (VAS). They will then be randomized to listen to music (2 songs chosen by them, maximum 10 minutes) or 10 minutes of noise cancelation. Participants will then be shown a series of images related to opioid use. They will complete the craving scale again. They will be shown a series of neutral images that do not pertain to drug use, and the craving scale will be administered again. Finally, they will complete the Absorption in Music Scale.
The second phase, for all participants regardless of randomization in the first phase, will be a qualitative interview asking subjects about their relationship with music, and how music pertained to their past drug use and/or recovery. Researchers will also ask participants about their experience participating in the trial and potential strategies to expand music use and recommendations in clinical settings for OUD.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02459
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Current diagnosis of opioid use disorder
- Actively receiving buprenorphine or methadone treatment with a stable dose of at least 30 days
Exclusion Criteria:
- Any significant impairment in mental status that would interfere with the ability to provided informed consent including suicidality, homicidality, or psychosis.
- Hearing impaired
- Vision impaired
- Patient reports that they are pregnant
- Requiring the use of any prescription opioid analgesics during the trial
- Currently prescribed naltrexone
- Chronic pain, defined as pain on the numeric rating scale (0-10) of >3 every day for over 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: music
In this arm, subjects will rate their cravings for opioids on a 0-100 point visual analog scale.
They will then listen to 2 songs of their choosing.
They will then be shown a series of images "cues" related to drug use, and will again be asked their cravings for opioids.
|
Subjects will listen to two songs of their choosing.
They will be prompted: "Please choose two songs that you really enjoy and that make you feel relaxed or take away stress".
|
|
Placebo Comparator: silence
In this arm, subjects will rate their cravings for opioids on a 0-100 point visual analog scale.
They will then listen to 10 minutes of silence.
They will then be shown a series of images "cues" related to drug use, and will again be asked their cravings for opioids.
|
Subjects will listen to 10 minutes of silence through high quality noise canceling headphones
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid Cravings
Time Frame: on Day 1
|
Subjects will rank their craving for opioids on a 100-point Visual Analog Scale before and after being shown drug-related cues (images).
The primary outcome will determine if there is a difference in craving levels in the music vs. silence groups.
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on Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott G Weiner, MD, MPH, Brigham and Women's Hospital
Publications and helpful links
General Publications
- Suzuki J, Martin B, Prostko S, Chai PR, Weiss RD. Cannabidiol Effect on Cue-Induced Craving for Individuals with Opioid Use Disorder Treated with Buprenorphine: A Small Proof-of-Concept Open-Label Study. Integr Med Rep. 2022 Aug 1;1(1):157-163. doi: 10.1089/imr.2022.0070. Epub 2022 Aug 26.
- Chai PR, Carreiro S, Ranney ML, Karanam K, Ahtisaari M, Edwards R, Schreiber KL, Ben-Ghaly L, Erickson TB, Boyer EW. Music as an Adjunct to Opioid-Based Analgesia. J Med Toxicol. 2017 Sep;13(3):249-254. doi: 10.1007/s13181-017-0621-9. Epub 2017 Jun 23.
- Chai PR, Schreiber KL, Taylor SW, Jambaulikar GD, Kikut A, Hasdianda MA, Boyer EW. The Feasibility and Acceptability of a Smartphone-Based Music Intervention for Acute Pain. Proc Annu Hawaii Int Conf Syst Sci. 2019 Jan 8;2019:3917-3925.
- Chai PR, Schwartz E, Hasdianda MA, Azizoddin DR, Kikut A, Jambaulikar GD, Edwards RR, Boyer EW, Schreiber KL. A Brief Music App to Address Pain in the Emergency Department: Prospective Study. J Med Internet Res. 2020 May 20;22(5):e18537. doi: 10.2196/18537.
- Colebaugh CA, Wilson JM, Flowers KM, Overstreet D, Wang D, Edwards RR, Chai PR, Schreiber KL. The Impact of Varied Music Applications on Pain Perception and Situational Pain Catastrophizing. J Pain. 2023 Jul;24(7):1181-1192. doi: 10.1016/j.jpain.2023.01.006. Epub 2023 Jan 14.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025P000151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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