Short-Term Exposure for PTSD

Marijuana Abuse Clinical Trial

— STEP  

Official title:

Marijuana Use, Extinction Learning, and Exposure Therapy in Individuals With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874898
• Other study ID #: STUDY00001289
• Secondary ID: 1R34DA040034-01A
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines how marijuana use affects processes related to recovery from chronic posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana use. This study will assess how individuals with PTSD with heavy or no marijuana use perform on a discriminative conditioning and extinction paradigm designed to measure fear extinction learning, and how they respond to a brief daily imaginal exposure treatment in regards to PTSD symptom reduction.

Description:

In this study, 36 patients with chronic PTSD and heavy marijuana use (heavy) and 36 patients with chronic PTSD and no marijuana use (no use) will be recruited to examine the effects of marijuana use on behavioral (emotional experiencing), physiological (skin conductance, acoustic startle) and biological (cortisol, blood pressure) responding on a well-established discriminative conditioning and extinction paradigm. To examine real world therapeutic implications, we will also examine how individuals with PTSD and heavy or no marijuana use differentially respond to a brief (6 session, 50 min) daily imaginal exposure (IE) treatment. Throughout treatment, we will monitor level of cannabis metabolites in urine samples of marijuana users to correlate effects to outcomes and preliminarily explore how varying levels of cannabis metabolites affect extinction processes. Independent evaluators will assess patients at baseline, 4 weeks, and 12 weeks following study entry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Current PTSD diagnosis based on DSM-5 criteria, with a minimum duration of 12 weeks since the traumatic event;

2. Between the age of 18 and 65;

3. Current heavy marijuana use (5+ days per week for 3+ months) or no marijuana use in the last 3 months

4. Current diagnosis of a cannabis use disorder based on DSM-5 or no current diagnosis of a substance use disorder

Exclusion Criteria:

1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5.

2. Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).

3. Unwilling or unable to discontinue current trauma-focused psychotherapy

4. Any previous experience with prolonged exposure (PE) treatment

5. No clear trauma memory or trauma before age 3

6. Unstable dose of psychotropic medications in the prior 3 months

7. Ongoing intimate relationship with the perpetrator (in assault related PTSD cases).

8. Current diagnosis of a substance use disorder according to DSM-5, other than marijuana in the last 3 months.

Related Conditions & MeSH terms

• Chronic Post-Traumatic Stress Disorder
• Marijuana Abuse
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Brief Imaginal Exposure
Psychoeducation and imaginal exposure components of full prolonged exposure, in which patients relive the trauma vividly and process thoughts and feelings related to it

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)	The PSS-I assesses symptoms of PTSD as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline, 4 week, and 12 week follow up to assess change in PTSD symptoms	12 Weeks
Primary	Treatment drop-out	Defined as completion of less than 5 of 6 sessions of IE treatment	2 Weeks
Secondary	Change in Quick Inventory of Depressive Symptomatology (QIDS-SR16)	The QIDS-SR16 assesses symptoms of depression as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline, 4 week, and 12 week follow up to assess change in depression symptoms.	baseline, 4 week, and 12 Weeks
Secondary	Change in Marijuana Problems Scale (MPS)	The MPS is a self-report that assesses the impacts of marijuana on various areas of life, including motivation and productivity, social relationships, work and finances, self-esteem, memory impairment, legal problems, and physical health. The MPS is administered at baseline, 4 week and 12 week follow up to assess change in marijuana abuse.	baseline, 4 week, and 12 Weeks
Secondary	Change in Marijuana Frequency and Quantity	The Marijuana Frequency and Quantity Scale assesses the frequency and quantity of marijuana use and is administered at baseline, 4 week and 12 week follow up to assess changes in marijuana use.	baseline, 4 week, and 12 Weeks