Mindfulness Meditation for Alcohol Relapse Prevention: A Feasibility Pilot Study

Aleksandra Zgierska, MD, PhD, a NIAAA clinical research fellow and a clinical instructor at the Department of Family Medicine, University of Wisconsin School of Medicine and Public Health, served as the principal investigator for the project: "Mindfulness Meditation for Alcohol Relapse Prevention: A Feasibility Pilot Study." This study, conducted between February and September of 2007, was funded by three small grant awards (Research Stimulation Grant Award from the American Academy of Family Physicians - Foundation; Research Stimulation Grant Award from the Wisconsin Academy of Family Physicians; and Small Grant Award from the UW DFM, Madison). Dr. Zgierska was assisted with this project by her mentors:

• Michael Fleming, MD MPH,
• Christopher Coe, PhD,
• Michael Miller, MD,
• David Rabago, MD
• Benjamin Craig, PhD
• Megan Zuelsdorff, BS, a research specialist at the DFM and the study coordinator, and
• Sahar Safavi, a UW undergraduate student.

Alcohol dependence is a common chronic mental health disorder with a significant individual and societal burden. Although treatment is known to improve outcomes in alcohol dependence, the prevention of alcohol relapse still remains a challenge. Mindfulness Meditation ("meditation"), an ancient technique promoting intentional regulation of attention, is promising and often used in clinical settings, but not a well-studied treatment for alcohol dependence.

The goal of this pilot study was to evaluate study methods feasibility and gather pilot data on efficacy of meditation for alcohol relapse prevention. Study participants were recruited from the Madison-based Intensive Outpatient Addiction Treatment Programs (IOPs). From 50 adult alcohol dependent IOP patients in an early recovery, 19 were enrolled into this 16-week prospective one-arm trial. Of 19 subjects, 4 dropped out early in the study and were lost to follow-up, and 15 completed the study.

The study intervention included an eight-week meditation course (eight two-hour weekly sessions) and at-home meditation practice during the whole study (30 min/day, 6 days/week), in addition to "standard of care" therapy received through subjects' regular addiction medicine providers. Outcome measures were self-reported (primary: alcohol consumption) and collected at baseline, 4, 8, 12 and 16 weeks, and biological (stress-responsive biomarkers: salivary cortisol and serum interleukin-6, IL-6), collected at baseline and 16 weeks.

Subjects (n=19, 53% female) averaged 38.4 (SD 8.6) years old. At enrollment, they were abstinent for 30.9 (SD 22.2) days. Subjects completing the study (n=15) attended 82% of meditation course sessions. During the study, subjects were abstinent on 94.5% (SD 7.4) of the study days, with 47% reporting complete abstinence and 47% reporting = one heavy drinking day. Throughout the study, subjects meditated on average 4.6 (SD 1.1) days/week; their severity of depression, anxiety, and stress, all documented relapse triggers, decreased (p<0.01). Alcohol craving severity showed a tendency to improve (p=0.08), and degree of mindfulness increased (p<0.01). Using a 10-point Likert scale (10= "very important/likely"), subjects rated the meditation course as very important in general (8.7, SD1.8), useful as a relapse prevention tool (8.5, SD2.1), and reported that they were very likely to continue meditation practice in the future (9.0, SD1.5). In qualitative responses, they listed:

• "gaining skills to reduce stress,"
• "coping with craving," and
• good group support as the most valuable aspects of the meditation training.

At baseline, cortisol and IL-6 concentrations were higher than normative values. At 16 weeks, IL-6 level decreased (n=12, p=0.05); changes in cortisol level (n=11) were not statistically significant. There have been no adverse events or side effects.

Results of this pilot study suggest study methods feasibility and the possibility of efficacy of meditation as an adjunctive therapy for relapse prevention in alcohol dependence.

Based on these pilot results, Dr. Zgierska, under the mentorship of Michael Fleming, MD, MPH, Christopher Coe, PhD, Michael Miller, MD, David Rabago, MD, Benjamin Craig, PhD and David Rakel, MD, applied for a NIH K23 grant award that is currently under review. If granted, Dr. Zgierska plans to conduct a randomized controlled trial evaluating efficacy of meditation as a therapy for relapse prevention in alcohol dependence.