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New treatment option for Post-Traumatic Stress Disorder
Official title Approach-Avoidance and Alcohol Challenge Study in PTSD
ClinicalTrials.gov ID: NCT06002633
What this study is testing
- What it's testing
- Individuals with posttraumatic stress disorder (PTSD) have greater prevalence of alcohol use disorders (AUDs), with this comorbidity associated with worse illness outcomes, yet there remains limited mechanistic understanding of how PTSD confers risk for AUD. Understanding risk factors that associate with and predict the development of AUDs in PTSD could inform interventions and prevention efforts to reduce the rate of this comorbidity and improve outcomes of both disorders.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 60. Healthy volunteers may be eligible.
You may be able to join if
- for all participants:
- between 21 and 60 years of age
- having consumed at least 4 (men) or 3 (women) drinks on at least two occasions over the last year
- for PTSD participants: \- Meeting diagnostic criteria for PTSD, confirmed by structured interview
- For all people
You likely can't join if
- include:
- history of significant medical illness, particularly if possible changes in cerebral tissue
- neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)
- full Scale IQ \<85
- contraindication to MRI scanning
- positive pregnancy test
See the full eligibility criteria
- for all participants:
- between 21 and 60 years of age
- having consumed at least 4 (men) or 3 (women) drinks on at least two occasions over the last year
- for PTSD participants: \- Meeting diagnostic criteria for PTSD, confirmed by structured interview
- For all people
- include:
- history of significant medical illness, particularly if possible changes in cerebral tissue
- neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)
- full Scale IQ \<85
- contraindication to MRI scanning
- positive pregnancy test
- severe alcohol use disorder
- current severe cannabis use disorder
- any current substance use disorder (other than alcohol, cannabis, or nicotine)
- scores \> 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)
- ever being in an abstinence-oriented treatment program for alcohol use
- reporting wanting to quit drinking but not being able to
- any medical, religious, or other reasons for not drinking alcohol
- history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
- an adverse reaction to alcoholic beverages
- reporting never consuming 4 (men) or 3 (women) or more drinks on at least two occasions over the last year
- unwillingness to have a friend or family member drive them home after the alcohol administration sessions
- Additional exclusion criteria for participants in PTSD and IPV-exposed but no PTSD groups:
- not taking medications for \>4 weeks (i.e. participants must be stable on meds)
- acute suicidality with intent
- Additional exclusion criteria for participants in IPV-exposure but no PTSD group: \- history of PTSD
- Additional exclusion criteria for healthy comparison people also include:
- any prior psychiatric hospitalizations
- lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, suicide attempt, or eating disorder
- greater than 1 month of lifetime psychotropic medication
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.