University of Illinois at Chicago
Chicago, Illinois, 60608, United States
Location status: Recruiting
Location contact
Hagar Hallihan
CONTACT
NCT Number: NCT05778734
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.
Interested in participating?
Request Info18 year–24 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60608, United States
Location status: Recruiting
Hagar Hallihan
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 is a behavior therapy that rewards individuals for evidence of positive change (alcohol abstinence).
Time frame: Up to 6months
Participants will be monitored for 6 months to assess alcohol abstinence by blood alcohol content.
Time frame: Baseline, 3months.
Measured by Alcohol Use Disorder and Associated Disabilities Interview Schedule-5. Change in AUD severity from baseline to 3 months.
Time frame: Baseline, 6months.
Measured by Alcohol Use Disorder and Associated Disabilities Interview Schedule-5. Change in AUD severity from baseline to 6 months.
Time frame: Up to 6months.
Measured by AUDIT. Participants will be monitored for up to 6 months. This is the number of participants who screen positive for AUD.
Time frame: Baseline, 3 months.
Measured by Rutgers Alcohol Problem Index (RAPI).
Time frame: Baseline, 6 months.
Measured by Rutgers Alcohol Problem Index (RAPI).
Time frame: Baseline, 3 months.
Measured by 90-day Timeline Followback (TLFB).
Time frame: Baseline, 6 months.
Measured by 90-day Timeline Followback (TLFB).
Time frame: Baseline, 3 months.
Measured by 90-day Timeline Followback (TLFB).
Time frame: Baseline, 6 months.
Measured by 90-day Timeline Followback (TLFB).
Time frame: Baseline, 3 months
Measured by Drinking Motives Questionnaire Revised (DMQ-R).
Time frame: Baseline, 6 months
Measured by Drinking Motives Questionnaire Revised (DMQ-R).
Time frame: Baseline, 3 months
Measured by Positive and Negative Affect Schedule (PANAS).
Time frame: Baseline, 6 months
Measured by Positive and Negative Affect Schedule (PANAS).
Time frame: Baseline, 3 months
Measured by Positive and Negative Affect Schedule (PANAS).
Time frame: Baseline, 6 months
Measured by Positive and Negative Affect Schedule (PANAS).
Time frame: Baseline, 3 months.
Measured by Functional magnetic resonance imaging (fMRI).
Time frame: 3 months
Measured by Client Satisfaction Questionnaire.
Time frame: 3 months
Measured by satisfaction from semi-structured interviews.
Time frame: 3 months
Participant adherence to the CM-PST intervention schedule will be assessed by documented session attendance.
Time frame: Up to 6 months.
Participant retention will be assessed throughout the study by monitoring the proportion of the sample retained at 3-months and 6-months.
Contact information is provided by the study sponsor or research team.
University of Illinois at Chicago
Other
StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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