Alcohol, Inflammation, and Mindfulness Study

This study was designed to evaluate the effect of two outpatient, individually-administered,
psychosocial interventions (Relapse Prevention vs. Mindfulness-Based Relapse Prevention).
Participants are recruited via mass media advertisements, flyers, and local outreach to
clinical providers that do not address substance use. This sample size provides adequate
statistical power for the research questions undertaken.

Participants are screened over the telephone and invited into the laboratory for a baseline
assessment. Immediately after the baseline assessment, participants are randomized to a
therapist and then to a treatment condition. At the end of each year, the distribution of
participants across conditions and therapists are evaluated for imbalances. If attrition has
resulted in an imbalance across conditions, the randomization procedure will be adjusted to
ensure equal numbers of participants in RP and MBRP.

Within a week of completing the baseline assessments, participants are seen by each
participant's individual therapist for a motivational interviewing, goal-setting session.
After the goal-setting session, the eight-session MBRP or RP treatments are administered. To
ensure that therapists adhere to treatment manuals, a checklist is provided consisting of the
primary content addressed each session. Further, questionnaires assessing mindfulness
practice and facets of mindfulness are administered at each assessment. At the most recent
RPPR, these questionnaires validated that participants in the MBRP condition were increasing
in some facets of mindfulness during treatment and up to three months after treatment (e.g.,
being nonjudgmental, nonreactive).

The investigators will conduct extensive analyses of any attrition encountered in the project
to determine bias. However, the research team will have the capability of using modern
approaches to the handling of missing data including full information maximum likelihood
estimation of missing data within Proc Mixed in SAS and within EQS.

The distributional properties of all continuously scaled variables will be examined for
skewness and kurtosis to determine the need for normalizing transformations or for
alternations to the analysis plan (i.e., generalized estimating equations or robust
estimation) prior to the primary analyses.

To confirm the validity of random assignment, pretest equivalence of the two treatment
conditions across demographics, drinking history, smoking, and all other baseline measures
will be assessed via t-tests on continuous items and chi-square tests of categorical items.
The investigators will use the Bonferroni approach to correct for alpha inflation with a
familywise alpha of .05. Any variables on which the two groups are unequal at pretest will be
covariates in all further analyses.

Attrition analyses will be conducted after each follow-up data collection effort to provide
assurance that differential attrition by treatment condition has not occurred. Following
previously published procedures, a series of ANOVAs of treatment (MBRP versus RP) X retention
(retained, not retained) will be conducted on continuous baseline measures. Significant
treatment X retention interactions identify measured variables on which differential
attrition may have occurred. The logit model analog procedure will be applied to categorical
baseline measures to test for differential attrition on categorical variables such as gender
and ethnicity. The investigators will conduct these analyses to assure that differential
attrition by treatment condition does not account for any of the effects of the treatments.

Inclusion Criteria:

1. Have a primary Diagnostic Statistical Manual-V (DSM-V) diagnosis of alcohol use
disorder;

2. Must be within 10 days of last drink;

3. Must have been drinking heavily (criteria dependent upon individual's age, gender, and
BMI) for a consistent period of time;

4. Must have a breath alcohol level of 0 at screening;

5. Must have a Clinical Institute Withdrawal Assessment (CIWA) score less than 8
(indicating no need for medical detox);

6. Must have expressed a desire during their initial screen to reduce the number of
drinks they regularly consume

Exclusion Criteria:

1. Currently taking any medications for the treatment of psychiatric disorders, including
substance use disorders, mood disorders, and psychosis;

2. Pregnant, as indicated by a pregnancy test which will be administered at baseline;

3. Positive for, sedatives, opiates, cocaine, or amphetamine on drug screen at baseline;

4. Meets criteria for psychotic disorder, bipolar disorder, or a major depressive episode