Overview

Neuroimaging and CBD for Heroin Use Disorder

Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
0
Participant gender:
All
Summary
The investigators propose an imaging study to investigate the neurobiological effects of CBD (vs placebo) in abstinent subjects with heroin use disorder (HUD). The purpose of the study is to determine the neural circuits and transmitters associated with the effects of CBD on to reduce craving and anxiety. The neuroimaging will be conducted in participants immediately following their first administration of CBD (800mg or placebo) and one week after the last administration (3 daily doses). This CBD administration protocol was shown in previous studies by the investigators to reduce craving and anxiety in abstinent heroin users.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hurd,Yasmin, Ph.D.
Collaborator:
GW Research Ltd
Treatments:
Cannabidiol
Epidiolex
Criteria
Inclusion Criteria:

1. Non-treatment seeking heroin use disorder (HUD) subjects who have been abstinent for
at least 7 days before enrollment

2. Opioid use disorder with criteria met in the past 3 months

3. No opioid use in the past 7 days

4. Subjects between 18 and 65 years old

5. Not naïve to cannabis

Exclusion Criteria:

1. Poor physical health (as determined by medical screen)

2. Breathalyzer positive for alcohol

3. Medical or psychiatric contraindications for MRI

4. Medical or psychiatric contraindications for CBD administration

5. Having a diagnosis of substance use disorder (except for heroin and nicotine) in the
past 3 months

6. Currently on any kind of OUD treatments

7. Being pregnant or breastfeeding

8. Not using an appropriate method of contraception

9. Positive drug screen

10. Participating in another pharmacotherapeutic trial in the past 3 months

11. Showing signs of acute heroin withdrawal symptoms

12. History of impaired renal function or elevated liver enzymes at prescreening

13. Subjects who are non-English speaking

14. Subjects who have been court mandated to attend treatments centers

15. Subjects who test positive for cannabinoid use