Alcohol Dependence
Conditions
Keywords
Alcohol Dependence, Alcoholism, Substance Use Disorders, Substance Abuse
Brief summary
The purpose of this 52-week clinical trial is to see if the meditation-based intervention, adjunctive to standard of care therapy, can reduce relapse and improve psychological health among adults recovering from alcohol dependence.
Detailed description
The goal of this partially-blinded, two-arm clinical trial was to test whether the Mindfulness Meditation Relapse Prevention (meditation), combined with 'standard of care' (SOC) therapy, is more effective in preventing a return to drinking than SOC alone (wait-list control) among adult recovering alcoholics. The intervention was manualized and based on existing models. It was proposed that meditation may improve outcomes of interest through reduction of the severity of stress-related relapse risk factors such as perceived stress, anxiety, depression, craving and emotion dysregulation, and the level of stress-sensitive biomarkers (cytokine interleukin-6, liver enzymes). For this study, 123 adult alcohol dependent subjects were recruited from collaborating treatment centers, randomly assigned to one of two equal study arms, and followed for 26-weeks (Period 1, Randomized Controlled Trial, RCT). The RCT evaluated the efficacy of the meditation intervention using self-reported alcohol consumption as primary, and drinking-related harms and subject treatment satisfaction and adherence as secondary outcomes. It also gathered preliminary data on potential mechanisms of meditation action. After the completion of their 26-week RCT (Period 1), controls were eligible to receive the meditation intervention (cross-over), and all participants were followed-up for additional 26 weeks (non-randomized Period 2). This study will provide evidence about the efficacy of meditation for alcohol relapse prevention, will further our understanding of relapse and the potential mechanisms of meditation action, direct future research and guide clinical decision-making.
Interventions
BEHAVIORALMindfulness Based Relapse Prevention for Alcohol Dependence
All subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. Experimental subjects also receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. The intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the study.
OTHERWait-list control
'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC.
Sponsors
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Alcohol dependence diagnosis * Completed at least 2 weeks of IOP or (IOP equivalent=at least 2 days per week) for alcohol dependence * Sober since beginning of outpatient treatment * English fluency; ability to fill out surveys * Permanent home address and telephone * At least 18 years old * Score \>13 on the Perceived Stress Scale
Exclusion criteria
* Pregnant * Alcohol abstinence \>14 weeks before enrollment * Current, regular meditation * Pre-existing bipolar, schizophrenia, or delusional disorder * Regular drug use (other than tobacco) in last 2 weeks * Inability to reliably participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Heavy Drinking Days | 26 weeks | Alcohol consumption as measured by percent heavy drinking days from baseline to 26 weeks. A heavy drinking day is defined as 4 or more drinks for women or 5 or more drinks for men, during a 24-hour period. |
| Percent Days Abstinent From Alcohol | 26 weeks | Measures percent days abstinent from alcohol |
| Time to Relapse (Resumption of Drinking) | 26 weeks | Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drinker Inventory of Consequences | 26 weeks | Severity of drinking related negative consequences as measured by the Drinker Inventory of Consequences (DrInC-2R). This inventory consists of 50 items rated on a scale of 0 to 3, with '0' indicating a given consequence did not happen, '1' indicating it almost happened, '2' indicating it did happen, and '3' indicating it happened more than once. The sum of all ratings (minus the 5 control questions) indicates the 'total score', with higher scores corresponding to more drinking related consequences. The 'total score' can range from 0 (did not happen) to 135 (happened all the time). |
| Subject Treatment Satisfaction | 8 weeks | Treatment satisfaction rating on a Likert scale of 1 to 7 (1 indicating 'extremely dissatisfied', 4 'neutral', and 7 'extremely satisfied'). |
| Subject Treatment Adherence | 8 weeks | Mindfulness Based Relapse Prevention for Alcohol Dependence intervention session attendance; adherence defined as attending 4 or more out of 8 total sessions. |
Countries
United States
Participant flow
Pre-assignment details
In the initial 26 weeks \[Period 1\], this was a randomized controlled trial. After the 26 week assessment, control participants were eligible to receive the meditation intervention, however, some elected not to receive the intervention \[non-randomized trial\]; all study participants were followed up for additional 26 weeks \[Period 2\].
Participants by arm
| Arm | Count |
|---|---|
| Meditation Mindfulness Based Relapse Prevention intervention + Standard of Care therapy
Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study. | 64 |
| Wait-list Control Standard of Care therapy only
Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC. | 59 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow up - Non-randomized | Withdrawal by Subject | 0 | 2 |
| Randomized Controlled Trial | Physician Decision | 1 | 0 |
| Randomized Controlled Trial | Withdrawal by Subject | 6 | 1 |
Baseline characteristics
| Characteristic | Meditation | Wait-list Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 59 Participants | 122 Participants |
| Age, Continuous | 40.5 years STANDARD_DEVIATION 12.1 | 41.9 years STANDARD_DEVIATION 11.9 | 41.2 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United States | 64 participants | 59 participants | 123 participants |
| Sex: Female, Male Female | 25 Participants | 28 Participants | 53 Participants |
| Sex: Female, Male Male | 39 Participants | 31 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 0 / 59 |
| serious Total, serious adverse events | 0 / 64 | 0 / 59 |
Outcome results
Primary
Percent Days Abstinent From Alcohol
Measures percent days abstinent from alcohol
Time frame: 26 weeks
Population: Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation | Percent Days Abstinent From Alcohol | 88.5 percent of days abstinent from alcohol | Standard Deviation 22.5 |
| Wait-list Control | Percent Days Abstinent From Alcohol | 94.1 percent of days abstinent from alcohol | Standard Deviation 11.6 |
Primary
Percent Heavy Drinking Days
Alcohol consumption as measured by percent heavy drinking days from baseline to 26 weeks. A heavy drinking day is defined as 4 or more drinks for women or 5 or more drinks for men, during a 24-hour period.
Time frame: 26 weeks
Population: Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation | Percent Heavy Drinking Days | 3.8 percentage of heavy drinking days | Standard Deviation 8.4 |
| Wait-list Control | Percent Heavy Drinking Days | 3.0 percentage of heavy drinking days | Standard Deviation 8.4 |
Primary
Time to Relapse (Resumption of Drinking)
Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.
Time frame: 26 weeks
Population: Only 105 participants provided data for this measure at 26-week follow up; due to participants either: declining participation for the visit, being unable to reach within the 26-week follow up time, or withdrawing from the study before 26-week follow up. Of the 105, 3 meditation/0 controls met criteria for having relapsed during this time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation | Time to Relapse (Resumption of Drinking) | 29.0 number of days to relapse | Standard Deviation 13 |
Secondary
Drinker Inventory of Consequences
Severity of drinking related negative consequences as measured by the Drinker Inventory of Consequences (DrInC-2R). This inventory consists of 50 items rated on a scale of 0 to 3, with '0' indicating a given consequence did not happen, '1' indicating it almost happened, '2' indicating it did happen, and '3' indicating it happened more than once. The sum of all ratings (minus the 5 control questions) indicates the 'total score', with higher scores corresponding to more drinking related consequences. The 'total score' can range from 0 (did not happen) to 135 (happened all the time).
Time frame: 26 weeks
Population: Only 98 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation | Drinker Inventory of Consequences | 11.3 Scores on a scale | Standard Deviation 16.9 |
| Wait-list Control | Drinker Inventory of Consequences | 16.5 Scores on a scale | Standard Deviation 17.6 |
Secondary
Subject Treatment Adherence
Mindfulness Based Relapse Prevention for Alcohol Dependence intervention session attendance; adherence defined as attending 4 or more out of 8 total sessions.
Time frame: 8 weeks
Population: Of 64 enrolled participants, one withdrew prior to the first intervention session. This participant's data was included in the baseline data analyses; this participant's meditation intervention attendance was counted as 0.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Meditation | Subject Treatment Adherence | 71.9 Percentage of meditation participants |
Secondary
Subject Treatment Satisfaction
Treatment satisfaction rating on a Likert scale of 1 to 7 (1 indicating 'extremely dissatisfied', 4 'neutral', and 7 'extremely satisfied').
Time frame: 8 weeks
Population: 48 participants provided data for this outcome measure at an 8-week follow up visit, and their responses were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation | Subject Treatment Satisfaction | 5.5 points | Standard Deviation 1.4 |