Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT05959434
Eligibility Criteria:
Inclusion Criteria:
1. Any gender identity, any race or ethnicity, aged 18-70 years.
2. Able to provide written informed consent.
3. Ability to understand English.
4. Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder ( \>= 4 criteria).
5. At least 3 to 4 heavy drinking days per week (4 or more drinks for a woman, 5 or more drinks for a man) in the last 30 days, or \>14 drinks per week for females or \> 21 drinks per week for males for at least 2 weeks in the last 30 days.
6. Meet DSM-5 diagnostic criteria for current (past month) PTSD as assessed by the CAPS-5.
7. Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders. The inclusion of participants with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and anxiety disorders among patients with AUD and PTSD. Concurrent substance use disorders are acceptable provided alcohol is the participant's primary substance of choice.
8. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.
Exclusion Criteria:
1. Meeting DSM-5 criteria for a history of or current psychotic disorder or bipolar disorder, or imminent risk of suicidal or homicidal behavior. The intervention may be insufficient, and those participants will be referred clinically for a higher level of care.
2. Participants on psychotropic medications which have been initiated during the past 4 weeks.
3. Acute alcohol withdrawal as indicated by CIWA-Ar scores \>8. Those participants will be referred clinically for medically supervised detoxification. They may be re-evaluated for eligibility after detoxification.
4. Pregnancy or breastfeeding for women.
5. Currently enrolled in evidence-based behavioral treatment for AUD or PTSD. Attendance at therapeutic activities (e.g., Alcoholics Anonymous) other than study sessions will be closely monitored using the Treatment Services Review.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05959434
Study Brief:
Protocol Section:
NCT05959434