Administration of Prazosin to Prevent PTSD in Adult Women After Sexual Assault

NCT03997864 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 19-0733
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to learn more about whether taking the medication, Prazosin, immediately and during the weeks immediately following a traumatic event can help to reduce the risk of developing posttraumatic stress disorder (PTSD). Early post traumatic event sleep disturbance predicts the later development of PTSD. Prazosin has shown some effectiveness in reducing trauma related nightmares and sleep disturbance. We hypothesize that regulating sleep immediately after a sexual assault will reduce PTSD and diminish symptoms.

Conditions

Posttraumatic Stress Disorder

Keywords

Sexual Assault; Trauma; prevention

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms and severity - Clinician-Administered PTSD Scale - 5 (CAPS-5)

  Clinician-Administered PTSD Scale-5 (CAPS-5) - Past Month \& Past Week. The CAPS is the gold standard in PTSD assessment and the total score will serve as the primary outcome. The CAPS-5 is a 30-item structured interview to make a current (past month) diagnosis of PTSD, a lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The full interview takes 45-60 minutes to administer and will be given at baseline, at approximately 31 days post event, and at three months.

  The full interview takes 45-60 minutes to administer and will be given at baseline, at approximately 31 days post event, and at three months.

Secondary Outcomes (3)

• Pittsburgh Sleep Quality Index (PSQI)

  The PSQI will be completed weekly through study completion (average three months).

• Pittsburgh Sleep Quality Index - Trauma Addendum (PSQI-A)

  The PSQI-A will be completed weekly through study completion (average three months).

• Patient Health Questionnaire (PHQ-9)

  It takes about five minutes to complete and will be assessed weekly for the first seven weeks of participation and at three months/study completion (at each study visit).

Study Arms (2)

Treatment - prazosin

ACTIVE COMPARATOR

Participants randomized to this group will receive the medication prazosin.

Drug: Prazosin

Control - placebo

PLACEBO COMPARATOR

Participants randomized to this group will receive placebo .

Drug: Placebos

Interventions

Prazosin DRUG

Starting dose: 2mg at HS. Maximum dose: 15 mg at HS. Dosage will be increased 1 mg every 3 days until sleep is improved, max dose is reached, or side effects are problematic. Tapering Decrease prazosin 1 mg every 3 days or 3 mgs per week until off completely. Tapering will take approximately 2-3 weeks.

Also known as: Minipress

Treatment - prazosin

Placebos DRUG

Starting dose: 2mg at HS. Maximum dose: 15 mg at HS. Dosage will be increased 1 mg every 3 days until sleep is improved max dose is reached, or side effects are problematic.

Control - placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Enrollment is limited to females for the purposes of limiting confounding factors in a small sample, and because many more females than males are treated for sexual assault.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients between the ages of 18 years and 50 years
• Victim of sexual assault/rape
• Able to understand consent procedure
• Discharged to home

You may not qualify if:

• Admitted to inpatient unit
• Previous diagnosis of PTSD
• Contra-indications to prazosin: orthostatic hypotension, right heart failure, use of anti-hypertensive medication, 5-phosphodiesterase inhibitors (sildenafil) or diuretic, history of syncope or severe unexplained faintness, known hypersensitivity to quinazolines
• Hemodynamically unstable
• Current use of over the counter, prescribed, or use of other drugs for insomnia
• Dependence on alcohol, opiates or other illegal drugs
• History of psychotic disorder
• Suicidal risk defined by a positive response on the 3-item assessment, standard protocol in the ED
• Current use of morphine or methadone
• Pregnant or breastfeeding
• Known hepatic dysfunction
• Cardiac or vascular history including coronary artery disease
• Narcolepsy
• History of sleep apnea
• Returning to chronic domestic abuse situation

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.

  PMID: 38767196 DERIVED

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.

  PMID: 35141873 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a randomized double-blind placebo-controlled trial. All study team personnel (PI, RAs) and study participants will be blinded to intervention condition \[prazosin (treatment) vs. placebo (control)\] throughout active data collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants in this study will include 40 adult females who complete consent (20 per arm), ages 18-50 years, who are evaluated and treated at the University of Colorado Hospital after an alleged sexual assault on their person. Randomization will be completed by the pharmacy and study condition (prazosin/treatment vs. placebo/control) masked throughout the data collection portion of the study. Participants will attend weekly visits during the 3-week medication trial and 2-3 week tapering off of medication, followed regular check-in phone calls with study staff between stopping the medication and the follow-up assessments at the final study visit (approx. 3 moths post study enrollment).

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 25, 2019
• Study Start: February 23, 2020
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)