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| Name | Class |
|---|---|
| San Francisco VA Health Care System | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AABM Training | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol Approach Bias Modification | Device | Computerized training |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility | The number of participants who enrolled and actually started study treatment over the 12-month recruitment period. | 12 months |
| 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. | 6 weeks |
| Tolerability Feasibility | Tolerability feasibility is measured by the number and percent of participants experiencing each adverse event. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven L. Batki, MD | University of California, San Francisco/San Francisco VA Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Health Care System | San Francisco | California | 94121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Feasibility | The number of participants who enrolled and actually started study treatment over the 12-month recruitment period. | 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. | Posted | Count of Participants | Participants | 12 months |
|
Beginning at baseline through the follow-up visit, for a total of 6 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AABM Training With ADP Sessions Before and After 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head tingling | Nervous system disorders | Non-systematic Assessment |
Of the 3 participants who were assigned to study treatment and who actually started study treatment, 1 participant was withdrawn from the study after ADP session 1. The reason for the study withdrawal was because of study physician decision, based on laboratory test evidence of substance use, making the participant ineligible for study continuation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven L. Batki, MD | University of California, San Francisco/San Francisco VA Health Care System | 415-221-4810 | 23671 | steven.batki@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 18, 2019 | Jun 6, 2022 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 6 weeks |
| 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. | 2 days (1 day each for ADP session 1 and 2) |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Count of Participants | Participants | 6 weeks |
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| Primary | Tolerability Feasibility | Tolerability feasibility is measured by the number and percent of participants experiencing each adverse event. | Posted | Count of Participants | Participants | 6 weeks |
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| 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. | One participant did not complete the either ADP session. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
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| 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. | One participant did not complete the either ADP session. | Posted | Mean | Standard Deviation | standard drinks | 2 days (1 day each for ADP session 1 and 2) |
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| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| Physically slow | General disorders | Non-systematic Assessment |
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| Sleepiness/tiredness | General disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Itchy/red eyes | Eye disorders | Non-systematic Assessment |
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| Title | Measurements |
|---|---|
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| Dizziness |
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| Itchy/red eyes |
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