StuDy AimED at Increasing AlCohol AbsTinEnce

Alcohol Use Disorder Clinical Trial

Official title:

StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778734
• Other study ID #: 2022-1047
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2023
• Est. completion date: May 31, 2028

Study information

• Verified date: March 2024
• Source: University of Illinois at Chicago
• Contact: Hagar Hallihan, PhD
• Phone: 312-413-5361
• Email: hhalli2[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the feasibility & acceptability of an integrated CM-PST intervention (in K99 phase) and preliminary efficacy (in R00 phase), vs. CM alone, to improve treatment efficacy and inform about neural mechanisms of treatment effects in young adults with Alcohol Use Disorder (AUD).

The aims are as follows:

K99 Aim: Test feasibility & acceptability of a developed CM-PST, by meeting these benchmarks:

2a Feasibility: enroll 20 participants in the new CM-PST in a single-arm pre- and post-study, and retain ≥85% at wk 12. 2b Deliver CM-PST at ≥90% fidelity to intervention protocol. 2c Acceptability to participants: Achieve mean score ≥3 on Client Satisfaction Scale Questionnaire and satisfaction from semi-structured interviews.

R00 Aim 1) Test preliminary efficacy of CM-PST in a 2-arm pilot RCT: Male/female young adults (aged18-24) who meet AUD criteria will be randomized to CM-PST or CM-only control, and assessed at baseline (0), 3, and 6 months. Primary study endpoint will be 3 months.

R00 Aim 2 (Exploratory) Explore potential neural mechanisms of CM-PST effects, by fMRI scanning & analyses of core regions of the brain circuits regulating positive affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex), and connectivity between these core regions.

Description:

Study Design Formative (K99 Phase), we will test feasibility & acceptability of integrated CM-PST. To test CM-PST, we will recruit/enroll 20 participants in a single-arm pre/post study. Participants who meet eligibility will be invited to our clinical lab at UIC for informed consent and baseline measures. Consenting participants will receive CM-PST intervention via videoconferences such as zoom, in 8 CM-PST individual sessions, every week for sessions 1-4 and every other week for sessions 5-8, over 12 weeks. Participants will complete the Client Satisfaction Scale survey after each session and 3 mo. post-intervention, to quantify their overall experiences with this new CM-PST.

Preliminary efficacy trial (R00 Phase). This will be a 2-arm Randomized control trial in young adults aged 18-24 yr who meet AUD criteria. Prospective participants who respond to our advertisements will be screened by phone for eligibility and to determine their AUD diagnostic status and severity (mild, moderate, severe). Participants who meet eligibility will be invited to our UIC clinical lab for informed consent, baseline self-report measures, urine alcohol screening, and baseline fMRI, and then randomized to either CM-PST (42 participants) or CM-only (42 participants) control group. All participants will complete follow-up assessments at 3 & 6 months with blinded outcome assessors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: May 31, 2028
• Est. primary completion date: May 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Male and female young adults aged 18-24 yr

• English-speaking

• Current alcohol use greater or equal to 1 day/week via phone screening, and meet criteria for (past year) mild, moderate or severe AUD on the AUDIT and AUDADIS surveys.

• Completion of written informed consent

• Baseline screening study visit.

Exclusion Criteria:

• Participation in past 6 mo. in AUD or substance use treatment

• Current use of medications used to treat AUD (e.g., naltrexone)

• Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder.

• Current use of psychoactive drugs, determined by positive drug toxicology screen

• Conditions (e.g., tic disorder) that would interfere with psychophysiological indices of reward functioning

• Pregnancy or intention to become pregnant

• Additional exclusion criteria pertaining to fMRI scan in R00 phase only: a) bodily ferrous metals (e.g., aneurysm clips, shrapnel/retained particles) or b) claustrophobia, inability to tolerate small enclosed spaces.

Related Conditions & MeSH terms

• Alcohol Abstinence
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• CM-PST
CM-PST is a tailored behavioral intervention that enables young adults with AUD to successfully manage and overcome everyday life challenges influencing their alcohol intake.
• CM only
CM is a behavior therapy that rewards individuals for evidence of positive change (alcohol abstinence).

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Acceptability (K99 phase only).	Measured by Client Satisfaction Questionnaire.	3 months
Other	Intervention Acceptability from interviews (K99 phase only).	Measured by satisfaction from semi-structured interviews.	3 months
Other	Intervention Fidelity (K99 phase only).	Participant adherence to the CM-PST intervention schedule will be assessed by documented session attendance.	3 months
Other	Participant Retention (K99 phase only).	Participant retention will be assessed throughout the study by monitoring the proportion of the sample retained at 3-months and 6-months.	Up to 6 months.
Primary	Alcohol abstinence.	Participants will be monitored for 6 months to assess alcohol abstinence by blood alcohol content.	Up to 6months
Secondary	Change in AUD severity at 3 months.	Measured by Alcohol Use Disorder and Associated Disabilities Interview Schedule-5. Change in AUD severity from baseline to 3 months.	Baseline, 3months.
Secondary	Change in AUD severity at 6 months.	Measured by Alcohol Use Disorder and Associated Disabilities Interview Schedule-5. Change in AUD severity from baseline to 6 months.	Baseline, 6months.
Secondary	Change in AUD screening status.	Measured by AUDIT. Participants will be monitored for up to 6 months. This is the number of participants who screen positive for AUD.	Up to 6months.
Secondary	Change in Alcohol-related negative consequences at 3 months.	Measured by Rutgers Alcohol Problem Index (RAPI).	Baseline, 3 months.
Secondary	Change in Alcohol-related negative consequences at 6 months.	Measured by Rutgers Alcohol Problem Index (RAPI).	Baseline, 6 months.
Secondary	Change in Alcohol use at 3 months.	Measured by 90-day Timeline Followback (TLFB).	Baseline, 3 months.
Secondary	Change in Alcohol use at 6 months.	Measured by 90-day Timeline Followback (TLFB).	Baseline, 6 months.
Secondary	Change in Drug use at 3 months.	Measured by 90-day Timeline Followback (TLFB).	Baseline, 3 months.
Secondary	Change in Drug use at 6 months.	Measured by 90-day Timeline Followback (TLFB).	Baseline, 6 months.
Secondary	Change in Reasons for drinking at 3 months.	Measured by Drinking Motives Questionnaire Revised (DMQ-R).	Baseline, 3 months
Secondary	Change in Reasons for drinking at 6 months.	Measured by Drinking Motives Questionnaire Revised (DMQ-R).	Baseline, 6 months
Secondary	Change in negative affect at 3 months.	Measured by Positive and Negative Affect Schedule (PANAS).	Baseline, 3 months
Secondary	Change in negative affect at 6 months.	Measured by Positive and Negative Affect Schedule (PANAS).	Baseline, 6 months
Secondary	Change in positive affect at 3 months.	Measured by Positive and Negative Affect Schedule (PANAS).	Baseline, 3 months
Secondary	Change in positive affect at 6 months.	Measured by Positive and Negative Affect Schedule (PANAS).	Baseline, 6 months
Secondary	Change in Neural target engagement of positive affect. affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex).	Measured by Functional magnetic resonance imaging (fMRI).	Baseline, 3 months.