Clinical trial NCT05778734: StuDy AimED at Increasing AlCohol AbsTinEnce
Official title: StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-03-21
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: K99 Phase is a single arm study, whiles the R00 phase is a 2-arm study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alcohol abstinence.
timeFrame: Up to 6months
Secondary outcomes:
measure: Change in AUD severity at 3 months.
timeFrame: Baseline, 3months.
measure: Change in AUD severity at 6 months.
timeFrame: Baseline, 6months.
measure: Change in AUD screening status.
timeFrame: Up to 6months.
measure: Change in Alcohol-related negative consequences at 3 months.
timeFrame: Baseline, 3 months.
measure: Change in Alcohol-related negative consequences at 6 months.
timeFrame: Baseline, 6 months.
measure: Change in Alcohol use at 3 months.
timeFrame: Baseline, 3 months.
measure: Change in Alcohol use at 6 months.
timeFrame: Baseline, 6 months.
measure: Change in Drug use at 3 months.
timeFrame: Baseline, 3 months.
measure: Change in Drug use at 6 months.
timeFrame: Baseline, 6 months.
measure: Change in Reasons for drinking at 3 months.
timeFrame: Baseline, 3 months
measure: Change in Reasons for drinking at 6 months.
timeFrame: Baseline, 6 months
measure: Change in negative affect at 3 months.
timeFrame: Baseline, 3 months
measure: Change in negative affect at 6 months.
timeFrame: Baseline, 6 months
measure: Change in positive affect at 3 months.
timeFrame: Baseline, 3 months
measure: Change in positive affect at 6 months.
timeFrame: Baseline, 6 months
measure: Change in Neural target engagement of positive affect. affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex).
timeFrame: Baseline, 3 months.
Other outcomes:
measure: Intervention Acceptability (K99 phase only).
timeFrame: 3 months
measure: Intervention Acceptability from interviews (K99 phase only).
timeFrame: 3 months
measure: Intervention Fidelity (K99 phase only).
timeFrame: 3 months
measure: Participant Retention (K99 phase only).
timeFrame: Up to 6 months.
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Hagar Hallihan
role: PRINCIPAL_INVESTIGATOR
References: