Neuroimaging and CBD for Heroin Use Disorder

Sponsor

Hurd,Yasmin, Ph.D. (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04567784

Collaborator

Jazz Pharmaceuticals (Industry)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heroin Abuse Opioid Use Disorder Substance-Related Disorders Opioid-Related Disorders	Drug: Cannabidiol (CBD) Drug: Placebo	Phase 2

Detailed Description

This study will first use multimodal imaging in abstinent subjects with HUD to determine the neural circuits associated with the effects of CBD on craving and anxiety. Secondly, the investigators will conduct 1H MRS to characterize in-vivo neurochemical levels associated with CBD administration. Altogether, the data obtained will fill critical gaps of knowledge important in the development of a potential non-opioid medication for treating opioid use disorder.

CBD has been shown to be safe in association with opioid use and not to have severe side effects. The oral CBD solution (Epidiolex) to be used in the current study is approved by the FDA for the treatment of seizures associated with two rare and severe forms of childhood epilepsy. This study will investigate the neurobiological effects of CBD which is critical for its development as a potential treatment for heroin use disorder in the future. Study participation duration will last 2 weeks and will include MRI imaging; CBD/placebo administration; MRI tasks such as the resting-state functional MRI (rs-fMRI); and questionnaires measuring craving, anxiety, depression, elements of cognitive function, and psychiatric history.

Screening: Study candidates will be recruited through flyers, ads and referrals from AIMS clinics. At the initial phone contact candidates will be screened for exclusion criteria and provided study information and, if they remain interested and no exclusion criteria are encountered, invited for in-person screening. Candidates will then undergo the informed consent procedure, be fully screened for eligibility and complete baseline assessments.

Randomization: Participants will be randomly assigned to either CBD or Placebo condition.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study is a randomized clinical trial in which subjects will receive either placebo or 800mg cannabidiol (CBD).This study is a randomized clinical trial in which subjects will receive either placebo or 800mg cannabidiol (CBD).

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Neuroimaging and CBD for Heroin Use Disorder

Actual Study Start Date :

Nov 12, 2020

Anticipated Primary Completion Date :

Nov 12, 2022

Anticipated Study Completion Date :

Nov 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study	Drug: Placebo Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
Experimental: CBD 800mg Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions	Drug: Cannabidiol (CBD) Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions

Arm

Intervention/Treatment

Placebo Comparator: Control

Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study

Drug: Placebo

Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study

Experimental: CBD 800mg

Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions

Drug: Cannabidiol (CBD)

Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions

Outcome Measures

Primary Outcome Measures

CBD effects on in vivo glutamatergic levels within mesocorticolimbic brain regions [2 MRI Scans (duration 30 mins)]
Effects of CBD on in-vivo glutamatergic levels within mesocorticolimbic brain regions using Proton-Magnetic resonance spectroscopy.
Change in fMRI BOLD signal during cue reactivity [2 MRI Scans (duration 15 mins)]
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during the cue reactivity task at the 2nd MRI conducted 1 week after intervention as compared to the 1st MRI.
Change in fMRI BOLD signal acquired during resting-state functional connectivity [2 MRI Scans (duration 10 mins)]
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during resting-state at the 2nd MRI conducted 1 week after intervention as compared to the 1st MRI.

Secondary Outcome Measures

Change in cue-induced drug craving on the VAS [1 week post-intervention]
Change in cue-induced drug craving will be measured through the Visual Analogue Scale for craving, 0 (not at all) to 10 (extremely) approximately 10 days after enrollment.
Change in cue-induced anxiety on the VAS [1 week post-intervention]
Change in cue-induced anxiety will be measured through the Visual Analogue Scale for anxiety, 0 (not at all) to 10 (extremely) approximately 10 days after enrollment.
Change in scores on the COWS [10 days]
Change in scores on the Clinical Opiate Withdrawal Scale (COWS), an 11-item structured instrument for assessing opiate withdrawal symptoms indicating mild (5-12), moderate (13-24), moderately severe (25-36) and severe (>36) withdrawal.
Systolic and diastolic blood pressure (in mmHg) [2 hours post-dose]
Change in blood pressure.
Heart rate (in beats/min) [2 hours post-dose]
Change in heart rate.

Other Outcome Measures

Adverse Events as assessed by the SAFTEE [post-intervention, approximately 1 week]
The Systematic Assessment for Treatment of Emergent Events (SAFTEE) is a structured instrument for collecting adverse drug effects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Non-treatment seeking heroin use disorder (HUD) subjects who have been abstinent for at least 7 days before enrollment
Opioid use disorder with criteria met in the past 3 months
No opioid use in the past 7 days
Subjects between 18 and 65 years old
Not naïve to cannabis

Exclusion Criteria:

Poor physical health (as determined by medical screen)
Breathalyzer positive for alcohol
Medical or psychiatric contraindications for MRI
Medical or psychiatric contraindications for CBD administration
Having a diagnosis of substance use disorder (except for heroin and nicotine) in the past 3 months
Currently on any kind of OUD treatments
Being pregnant or breastfeeding
Not using an appropriate method of contraception
Positive drug screen
Participating in another pharmacotherapeutic trial in the past 3 months
Showing signs of acute heroin withdrawal symptoms
History of impaired renal function or elevated liver enzymes at prescreening
Subjects who are non-English speaking
Subjects who have been court mandated to attend treatments centers
Subjects who test positive for cannabinoid use