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Contingency Management for PTSD (FOCUS Trial)

N/A

Recruiting

Led By Jean C Beckham, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current PTSD diagnosis

Be older than 18 years old

Must not have

Become hospitalized for psychiatric reasons

Meet diagnostic criteria for bipolar disorder or schizophrenia (note that the SCID-5 (First et al., 2015) will be used to diagnoses these and other disorders)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post-treatment (approximately six weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of reduced cannabis use on functioning for veterans with PTSD. The hypothesis is that less cannabis use will lead to better functioning.

Who is the study for?

This trial is for U.S. Veterans with PTSD who frequently use cannabis (13+ days in the past month) and can communicate in English. It's not open to those who've changed psychiatric meds recently, are getting non-study treatment for Cannabis Use Disorder, have been hospitalized or imprisoned, or have bipolar disorder, schizophrenia, or a substance use disorder other than cannabis.

What is being tested?

The FOCUS trial investigates whether reducing cannabis use improves daily functioning in Veterans with PTSD. The study uses Contingency Management (CM), which rewards individuals for meeting goals like reduced substance use.

What are the potential side effects?

Since this study focuses on reducing cannabis use rather than administering drugs, it does not directly involve side effects from interventions. However, participants may experience withdrawal symptoms from lessened cannabis usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PTSD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been hospitalized for mental health reasons.

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I have been diagnosed with bipolar disorder or schizophrenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post-treatment (approximately six weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post-treatment (approximately six weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-treatment (approximately six weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cannabis use

Change in functional impairment as measured by the Inventory of Psychosocial Functioning (IPF)

Change in functional impairment as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS)

+4 more

Side effects data

From 2021 Phase 2 trial • 118 Patients • NCT02896712

Nausea

Headache

Not Sleeping Well

Suicidal Ideation

Vomiting

Shortness of Breath

Domestic Violence/Abuse

Stomach Flu

Tremor

Stomach Pain

Muscle Aches

Cough

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only

Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only

Phase 2: ACT Plus CM Only

Phase 2: ACT Plus CM, With Placebo

Phase 2: ACT Plus CM, With Modafinil

Phase 2: DC Plus CM Only

Phase 2: DC Plus CM, With Placebo

Phase 2: DC Plus CM, With Modafinil

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Contingency Management (CM)Experimental Treatment1 Intervention

Mobile contingency management (CM) will be used to promote reductions in cannabis use among Veterans with PTSD who are heavy cannabis users. CM is an intensive behavioral therapy in which participants are paid to reduce substance use.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contingency Management (CM)

2016

Completed Phase 2

~480

0 / 3Eligibility criteria met