Alcohol Use Disorder
Conditions
Keywords
human laboratory, alcohol approach bias modification, alcohol use disorder, non-treatment seeking
Brief summary
The overall goal of the proposed project is to improve the treatment of individuals with Alcohol Use Disorder (AUD). We will conduct a pilot feasibility trial of Approach Bias Modification (AABM) training of heavy-drinking non-treatment seeking individuals with AUD. We will measure feasibility with respect to recruitment, retention and tolerability of AABM training and the Alcohol Drinking Paradigm (ADP). We will also assess changes in alcohol craving and alcohol consumption during ADP sessions conducted before and after 2 weeks of AABM training.
Detailed description
Heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will receive 2 weeks of AABM training preceded and followed by a 1-day ADP session. AABM training is a computer training program that participants interact with by pushing and pulling a joystick. Participants are asked to respond to the format of a presented picture, irrespective of the pictures' content. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. Training is conducted in 3 sessions per week for 2 weeks, for a total of 6 sessions. The ADP session is a one day human laboratory session taking place at the SFVA Medical Center. This human laboratory session involves the self-administration of alcoholic beverages by research participants under highly structured, observed conditions in order to evaluate the effects of the study intervention (AABM training) on alcohol craving and alcohol consumption. The investigators hoped to recruit 12 participants to enroll and start the clinical trial over the course of 1 year.
Interventions
DEVICEAlcohol Approach Bias Modification
Computerized training
Sponsors
San Francisco VA Health Care System
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men, ages 21-50; 2. Able to read English and to complete study evaluations; 3. Risky (also known as high-risk, or hazardous, or heavy) alcohol use, defined as 25-70 standard drinks per week on average over the past 30 days; Heavy (also known as risky, high-risk, or hazardous) alcohol use, defined as 15-70 standard drinks per week on average over the past 30 days. 4. No more than 3 days/week of alcohol abstinence in the past 30 days, to maximize likelihood that participants will choose to drink during the laboratory sessions. 5. At least 1 heavy drinking day (\> 5 drinks/day) per week on average during the 30 days prior to screening.
Exclusion criteria
1. Individuals who are seeking AUD treatment or have been in treatment within the past 6 months; 2. Current DSM-V non-alcohol use disorder other than tobacco and marijuana; 3. Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines, or barbiturates; 4. Regular use of psychoactive drugs including antipsychotics, anxiolytics and antidepressants during the 30 days prior to entry, as well as anticonvulsants, beta blockers, central nervous system stimulants or depressants, or other drugs that cause excessive sedation; 5. Psychosis or any other serious mental illness as judged by SCID and study physician assessment; 6. Medical conditions that in the judgment of the study physician contraindicate the consumption of alcohol or would make study participation hazardous; 7. History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a Clinical Institute Withdrawal Assessment Scale (CIWA-AD) score \> 8; 8. Participants who report disliking beer will be excluded because beer will be provided during the alcohol self-administration periods; 9. Participants who have taken any investigational drug within 4 weeks preceding study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | 12 months | The number of participants who enrolled and actually started study treatment over the 12-month recruitment period. |
| Retention Feasibility | 6 weeks | Retention feasibility as measured by the percentage of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 2-week course of 6 AABM training sessions. |
| Tolerability Feasibility | 6 weeks | Tolerability feasibility is measured by the number and percent of participants experiencing each adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Craving | 6 weeks | Alcohol craving will be measured during ADP sessions 1 and 2 using the Alcohol Urge Questionnaire (AUQ). Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1 and 2, using the total score of the Alcohol Urge Questionnaire (AUQ). The AUQ has 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7; items 2 and 7 are reverse scored). Higher scores reflect greater craving. Total score range is from a minimum of 8 to a maximum of 56. The AUQ is administered before alcohol administration and at various times after alcohol administration. The AUQ score reported here is the highest AUQ score obtained for that ADP session. |
| Alcohol Consumption (Number of Standard Drinks Consumed) | 2 days (1 day each for ADP session 1 and 2) | Alcohol consumption will be measured during ADP sessions 1 and 2 using the number of alcoholic standard drinks consumed during ADP session 1 (before 2 weeks of AABM training) and ADP session 2 (after the 2 weeks of AABM training). Consumption was measured using the number of alcoholic standard drinks consumed during the ADP sessions. A standard drink per NIAAA definition is 14 grams of pure alcohol. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AABM Training Alcohol Approach Bias Modification (AABM) training is a computer training program that participants interact with by pushing and pulling a joystick. Participants are asked to respond to the format of a presented picture, irrespective of the pictures' content. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. AABM training consists of 3 sessions per week over 2 weeks, for a total of 6 sessions.
Alcohol Approach Bias Modification: Computerized training | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | AABM Training |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Recruitment Feasibility
The number of participants who enrolled and actually started study treatment over the 12-month recruitment period.
Time frame: 12 months
Population: The analysis population consists of the target number (12) of participants that the investigators hoped to recruit and start on study treatment over a 12-month period. There appears to be an inconsistency only because the actual number of participants recruited and started on study treatment over the 12-month period was only 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AABM Training | Recruitment Feasibility | 3 Participants |
Primary
Retention Feasibility
Retention feasibility as measured by the percentage of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 2-week course of 6 AABM training sessions.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AABM Training | Retention Feasibility | 2 Participants |
Primary
Tolerability Feasibility
Tolerability feasibility is measured by the number and percent of participants experiencing each adverse event.
Time frame: 6 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AABM Training | Tolerability Feasibility | Head tingling | 1 Participants |
| AABM Training | Tolerability Feasibility | Physically slow | 1 Participants |
| AABM Training | Tolerability Feasibility | Sleepiness | 2 Participants |
| AABM Training | Tolerability Feasibility | Dizziness | 1 Participants |
| AABM Training | Tolerability Feasibility | Itchy/red eyes | 1 Participants |
Secondary
Alcohol Consumption (Number of Standard Drinks Consumed)
Alcohol consumption will be measured during ADP sessions 1 and 2 using the number of alcoholic standard drinks consumed during ADP session 1 (before 2 weeks of AABM training) and ADP session 2 (after the 2 weeks of AABM training). Consumption was measured using the number of alcoholic standard drinks consumed during the ADP sessions. A standard drink per NIAAA definition is 14 grams of pure alcohol.
Time frame: 2 days (1 day each for ADP session 1 and 2)
Population: One participant did not complete the either ADP session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AABM Training | Alcohol Consumption (Number of Standard Drinks Consumed) | ADP 1 | 1.5 standard drinks | Standard Deviation 2.12 |
| AABM Training | Alcohol Consumption (Number of Standard Drinks Consumed) | ADP 2 | 0.5 standard drinks | Standard Deviation 0.71 |
Secondary
Alcohol Craving
Alcohol craving will be measured during ADP sessions 1 and 2 using the Alcohol Urge Questionnaire (AUQ). Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1 and 2, using the total score of the Alcohol Urge Questionnaire (AUQ). The AUQ has 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7; items 2 and 7 are reverse scored). Higher scores reflect greater craving. Total score range is from a minimum of 8 to a maximum of 56. The AUQ is administered before alcohol administration and at various times after alcohol administration. The AUQ score reported here is the highest AUQ score obtained for that ADP session.
Time frame: 6 weeks
Population: One participant did not complete the either ADP session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AABM Training | Alcohol Craving | ADP 1 | 27.3 score on a scale | Standard Deviation 6.3 |
| AABM Training | Alcohol Craving | ADP 2 | 23.3 score on a scale | Standard Deviation 2.6 |