Alcohol Use DisorderNCT05778734
StuDy AimED at Increasing AlCohol AbsTinEnce
A study testing CM-PST and CM only in people with Alcohol Use Disorder, run by University of Illinois at Chicago at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- CM-PST and CM only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2023to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60608
Hagar Hallihan
About this study
Official title: StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)
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:
Read more
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- CM-PST, CM only
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM-PSTBehavioural
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 onlyBehavioural
CM is a behavior therapy that rewards individuals for evidence of positive change (alcohol abstinence).
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Other | For 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. Receives: Behavioral: CM-PST |
| Control group | Other | For 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. Receives: Behavioral: CM only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol abstinence.
Participants will be monitored for 6 months to assess alcohol abstinence by blood alcohol content.
Measured: Up to 6months
Secondary outcomes (16)
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.
Measured: Baseline, 3months.
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.
Measured: Baseline, 6months.
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.
Measured: Up to 6months.
Change in Alcohol-related negative consequences at 3 months.
Measured by Rutgers Alcohol Problem Index (RAPI).
Measured: Baseline, 3 months.
Change in Alcohol-related negative consequences at 6 months.
Measured by Rutgers Alcohol Problem Index (RAPI).
Measured: Baseline, 6 months.
Change in Alcohol use at 3 months.
Measured by 90-day Timeline Followback (TLFB).
Measured: Baseline, 3 months.
Change in Alcohol use at 6 months.
Measured by 90-day Timeline Followback (TLFB).
Measured: Baseline, 6 months.
Change in Drug use at 3 months.
Measured by 90-day Timeline Followback (TLFB).
Measured: Baseline, 3 months.
Change in Drug use at 6 months.
Measured by 90-day Timeline Followback (TLFB).
Measured: Baseline, 6 months.
Change in Reasons for drinking at 3 months.
Measured by Drinking Motives Questionnaire Revised (DMQ-R).
Measured: Baseline, 3 months
Change in Reasons for drinking at 6 months.
Measured by Drinking Motives Questionnaire Revised (DMQ-R).
Measured: Baseline, 6 months
Change in negative affect at 3 months.
Measured by Positive and Negative Affect Schedule (PANAS).
Measured: Baseline, 3 months
Change in negative affect at 6 months.
Measured by Positive and Negative Affect Schedule (PANAS).
Measured: Baseline, 6 months
Change in positive affect at 3 months.
Measured by Positive and Negative Affect Schedule (PANAS).
Measured: Baseline, 3 months
Change in positive affect at 6 months.
Measured by Positive and Negative Affect Schedule (PANAS).
Measured: Baseline, 6 months
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).
Measured: Baseline, 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start30 Jul 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- K99 Phase is a single arm study, whiles the R00 phase is a 2-arm study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Hagar Hallihan, University of Illinois at Chicago
- Investigators
- Hagar Hallihan, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778734
- Sponsor's protocol ID
- 2022-1047
- Status last verified
- May 2026
- First submitted
- 27 Feb 2023
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40829841
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)
- ClinicalTrials.gov ID
- NCT05778734
- Acronym / sponsor ID
- 2022-1047
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- K99 Phase is a single arm study, whiles the R00 phase is a 2-arm study.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Behavioral: CM-PSTFor 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 | Other | Behavioral: CM onlyFor 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM-PSTCM-PST is a tailored behavioral intervention that enables young adults with AUD to successfully manage and overcome everyday life challenges influencing their alcohol intake. | Behavioural | Treatment group |
| CM onlyCM is a behavior therapy that rewards individuals for evidence of positive change (alcohol abstinence). | Behavioural | Control group |
Primary outcome
Alcohol abstinence.
Time frame: Up to 6months
Participants will be monitored for 6 months to assess alcohol abstinence by blood alcohol content.
16 secondary outcomes
Change in AUD severity at 3 months.
Time frame: Baseline, 3months.
Change in AUD severity at 6 months.
Time frame: Baseline, 6months.
Change in AUD screening status.
Time frame: Up to 6months.
Change in Alcohol-related negative consequences at 3 months.
Time frame: Baseline, 3 months.
Change in Alcohol-related negative consequences at 6 months.
Time frame: Baseline, 6 months.
Change in Alcohol use at 3 months.
Time frame: Baseline, 3 months.
Change in Alcohol use at 6 months.
Time frame: Baseline, 6 months.
Change in Drug use at 3 months.
Time frame: Baseline, 3 months.
Change in Drug use at 6 months.
Time frame: Baseline, 6 months.
Change in Reasons for drinking at 3 months.
Time frame: Baseline, 3 months
Change in Reasons for drinking at 6 months.
Time frame: Baseline, 6 months
Change in negative affect at 3 months.
Time frame: Baseline, 3 months
Change in negative affect at 6 months.
Time frame: Baseline, 6 months
Change in positive affect at 3 months.
Time frame: Baseline, 3 months
Change in positive affect at 6 months.
Time frame: Baseline, 6 months
Change in Neural target engagement of positive affect. affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex).
Time frame: Baseline, 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 40829841Hallihan 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hagar Hallihan principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CM-PST and CM only in people with Alcohol Use Disorder, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hagar Hallihan, PhD (312-413-5361, hhalli2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol abstinence. (time frame: Up to 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.