PFI Hazardous Drinkers With Subclinical PTSD

Status unconfirmed · Not applicable

Conditions studied: Hazardous Drinking, Posttraumatic Stress Disorder

In brief

The objective of the present study is to assist on a randomized controlled trial (RCT), aimed at developing and testing the efficacy of a novel computer based PFI among hazardous drinkers with at least subclinical posttraumatic stress disorder (PTSD) (i.e., endorsing at least two symptoms in each PTSD symptom cluster) and elevated anxiety sensitivity (AS). The objective of this trial is to examine the feasibility, acceptability, and efficacy of this novel PFI on (1) primary outcomes including drinking motivational factors and alcohol-related behaviors and (2) secondary outcomes including changes in AS and PTSD, and (3) exploring theoretically relevant mediators/moderators. Follow-up assessments will occur at post-test, one-week, and one-month post-intervention. Hazardous drinkers with at least subclinical PTSD and elevated AS (N=100) recruited from the community will be randomly assigned to receive Alcohol-PTSD-PFI (AP-PFI) or an active comparison condition (C-PFI).

Key facts

Study ID

NCT04836442

Run by

University of Houston

People needed

100

Starts

2022-07-01

Expected to finish

2023-07-01

Last updated by the study team

2022-07-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥ 21 years of age
• Current hazardous drinking pattern (AUDIT scores ≥ 8 for males and ≥ 7 for females; this approach does not exclude persons with alcohol use disorder)
• Lifetime exposure to a DSM-5 Criterion A traumatic event and endorsing at least two symptoms in each DSM-5 PTSD symptom cluster.
• Elevated AS score (1 SD above normative mean)
• Fluent in English

You may not qualify if…

• Concurrent alcohol or other substance use treatment
• Current/past bipolar or psychotic disorder
• Current imminent risk of suicidality (i.e., past month ideation with intent or plan)
• Current stable use of prescription opioids/ benzodiazepines/positive urine drug screen
• Current pregnancy
• Inability to provide verbal or written consent
• Breath analysis (Alco-Sensor FST) estimating blood alcohol concentration (BAC) above 0

Where it is running

• Anxiety and Health Research Lab- Substance Use Treatment Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

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