NCT06982443 Wellness, Alcohol, Vitals, and Emotions
| NCT ID | NCT06982443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of New Mexico |
| Condition | Alcohol Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-10-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to examine the effects of mindfulness based relapse prevention on self-regulation overtime and drinking in daily life through the use of wearable heart rate sensors during mindfulness groups and answering assessment questions 3 times per day during the course of treatment. The main questions that it aims to answer are: 1. What changes in self-regulation as measured through heart rate variability are observed during a mindfulness intervention and how do those self-regulatory changes affect drinking after treatment? 2. How do changes in heart rate variability affect drinking, craving, and negative affectivity in daily life? Participants will: 1. Answer questions related to their mood and drinking behaviors. 2. Wear their sensors during an 8-week treatment period with 1 group per week. 3. Answer questions 3 times a day during the treatment period. 4.) Return their sensors via a pre-stamped package and answer questions about their mood and drinking behaviors 3- and 6-months after the mindfulness groups end.
Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older 2. Meet criteria for a moderate to severe alcohol use disorder within the previous 3-months. 3. Able to attend group meetings at the time listed on the recruitment materials. 4. Willing to wear a sensor for the 8-week intervention period and return the sensor after the immediate follow-up. 5. Have a phone/tablet/computer with internet access. 6. Be able to comprehend and consent to study requirements in English. 7. Have access to a valid U.S. mailing address for receiving the HRV sensors and reside in the United States. Exclusion Criteria: 1. Current symptoms of psychosis or mania. 2. Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification). 3. Have a history of pulmonary or cardiovascular disease that interferes with sensor data collection and HRV metrics (i.e., ectopic beats, arrythmia, congenital heart disease).
Contact & Investigator
Matison W McCool, Phd
PRINCIPAL INVESTIGATOR
Center on Alcohol, Substance use, And Addictions - The University of New Mexico
Frequently Asked Questions
Who can join the NCT06982443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alcohol Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06982443 currently recruiting?
Yes, NCT06982443 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of New Mexico to inquire about joining.
Where is the NCT06982443 trial being conducted?
This trial is being conducted at Albuquerque, United States.
Who is sponsoring the NCT06982443 clinical trial?
NCT06982443 is sponsored by University of New Mexico. The principal investigator is Matison W McCool, Phd at Center on Alcohol, Substance use, And Addictions - The University of New Mexico. The trial plans to enroll 120 participants.