NCT02874898

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

6.2 years

First QC Date

August 16, 2016

Last Update Submit

August 19, 2022

Conditions

Chronic Post-Traumatic Stress DisorderMarijuana Abuse

Outcome Measures

Primary Outcomes (2)

  • 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

  • Treatment drop-out

    Defined as completion of less than 5 of 6 sessions of IE treatment

    2 Weeks

Secondary Outcomes (3)

  • Change in Quick Inventory of Depressive Symptomatology (QIDS-SR16)

    baseline, 4 week, and 12 Weeks

  • Change in Marijuana Problems Scale (MPS)

    baseline, 4 week, and 12 Weeks

  • Change in Marijuana Frequency and Quantity

    baseline, 4 week, and 12 Weeks

Study Arms (2)

Heavy marijuana use

ACTIVE COMPARATOR

Heavy marijuana users with PTSD

Behavioral: Brief Imaginal Exposure

No marijuana use

ACTIVE COMPARATOR

Non-marijuana users with PTSD

Behavioral: Brief Imaginal Exposure

Interventions

Brief Imaginal ExposureBEHAVIORAL

Psychoeducation and imaginal exposure components of full prolonged exposure, in which patients relive the trauma vividly and process thoughts and feelings related to it

Heavy marijuana useNo marijuana use

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current PTSD diagnosis based on DSM-5 criteria, with a minimum duration of 12 weeks since the traumatic event;
  • Between the age of 18 and 65;
  • Current heavy marijuana use (5+ days per week for 3+ months) or no marijuana use in the last 3 months
  • Current diagnosis of a cannabis use disorder based on DSM-5 or no current diagnosis of a substance use disorder

You may not qualify if:

  • Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5.
  • 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).
  • Unwilling or unable to discontinue current trauma-focused psychotherapy
  • Any previous experience with prolonged exposure (PE) treatment
  • No clear trauma memory or trauma before age 3
  • Unstable dose of psychotropic medications in the prior 3 months
  • Ongoing intimate relationship with the perpetrator (in assault related PTSD cases).
  • Current diagnosis of a substance use disorder according to DSM-5, other than marijuana in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticMarijuana Abuse

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Michele A Bedard-Gilligan, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 22, 2016

Study Start

June 1, 2016

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)