StuDy AimED at Increasing AlCohol AbsTinEnce
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2023
CompletedFirst Posted
Study publicly available on registry
March 21, 2023
CompletedStudy Start
First participant enrolled
July 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
May 7, 2026
May 1, 2026
4.4 years
February 27, 2023
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Alcohol abstinence.
Participants will be monitored for 6 months to assess alcohol abstinence by blood alcohol content.
Up to 6months
Secondary Outcomes (16)
Change in AUD severity at 3 months.
Baseline, 3months.
Change in AUD severity at 6 months.
Baseline, 6months.
Change in AUD screening status.
Up to 6months.
Change in Alcohol-related negative consequences at 3 months.
Baseline, 3 months.
Change in Alcohol-related negative consequences at 6 months.
Baseline, 6 months.
- +11 more secondary outcomes
Other Outcomes (4)
Intervention Acceptability (K99 phase only).
3 months
Intervention Acceptability from interviews (K99 phase only).
3 months
Intervention Fidelity (K99 phase only).
3 months
- +1 more other outcomes
Study Arms (2)
Treatment group
OTHERFor the R00 phase: CM-PST treatment group will receive CM-PST intervention, which will consist of 8 sessions total, delivered remotely via Zoom videoconferences in individual sessions over 12 weeks. The first 4 sessions will be delivered weekly, and the remaining 4 sessions every other week. CM-PST will teach participants problem-solving skills using a structured 5-step method. In addition, participants will receive incentives for alcohol abstinence and submission of urine samples twice/wk. K99 phase participants will also receive CM-PST intervention.
Control group
OTHERFor the R00 phase: Participants in CM-only control will receive incentives for alcohol abstinence and submission of urine samples twice/wk. Participant incentives will start at a $10 gift card, with a $5 increase each subsequent measurement point on which alcohol is not detected or reported, to a maximum of $25, but no gift card on days when alcohol use is detected or reported, and the gift card reinforcer value will be re-set to $10.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60608, United States
Related Publications (1)
Hallihan H, Lee S, Rospenda KM, Wu Y, Adomah R, Knepper A, Ma J. Feasibility and acceptability of contingency management and problem-solving therapy intervention for enhancing alcohol abstinence: a single-arm, mixed methods pilot clinical trial. BMJ Open. 2025 Aug 19;15(8):e098691. doi: 10.1136/bmjopen-2024-098691.
PMID: 40829841DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hagar Hallihan
University of Illinois at Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 27, 2023
First Posted
March 21, 2023
Study Start
July 30, 2023
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
April 30, 2028
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After analyzing.
We will adhere to the NIH Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources issued December 23, 1999. Data from this research will be shared and the results of this research will be made available via publication in scientific journals and through scientific meetings where our findings are reported. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with typical scientific practices. All publications will be made publicly available consistent with NIH policies.