Opiate AddictionPhase 2NCT02539823

Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans

A Phase 2 study testing CBD 400 mg and CBD 800 mg in people with Opiate Addiction, run by Hurd,Yasmin, Ph.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Despite the current available therapies for opioid-dependent patients, most patients relapse. This research project focuses on the development of a novel compound, cannabidiol, to modulate opioid craving in humans based on animal models showing its selective effectiveness to inhibit drug-seeking behavior. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Opiate Addiction
What is being tested?: CBD 400 mg and CBD 800 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteUnited States
Study dates: Sep 2015to 24 May 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must be between 21 and 65 years old
Must have an opiate dependence that meets criteria set in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Structured Clinical Interview for DSM (SCID-V) over the last three months
No opioid use in the past 7 days (will be verified via urine drug screen and opiate metabolite test)

Who cannot join

Using any psychoactive drug (other than nicotine) any time up to test session 3
Having a diagnosis of drug dependence (except for heroin or nicotine) in the past 3 months, based on the SCID-V interview criteria
Being maintained on methadone or buprenorphine, or taking opioid antagonists such as naltrexone
Having a positive a drug screen
Showing signs of acute heroin withdrawal symptoms
Having medical conditions, including Axis I psychiatric conditions under DSM-V (examined using the Mini International Neuropsychiatric Interview [MINI])

Show all 12Show fewer

Having a a history of cardiac disease, arrhythmias, head trauma, and seizures
Having a history of hypersensitivity to cannabinoids
Arriving to the study site visibly intoxicated as determined by a clinical evaluation for signs and symptoms of intoxication and as verified by a drug screen
Participating in a another pharmacotherapeutic trial in the past 3 months
Being pregnant of breastfeeding
Not using or irregularly using appropriate methods of contraception such as hormonal contraceptives (e.g., Depo-Provera, Nuva-Ring), an intrauterine device (IUD), or double barrier method (combination of any two barrier methods used simultaneously, e.g., condoms, spermicide, diaphragms)

Trial locations and contacts

1 site in 1 country.

United States1 site

Mount Sinai Beth Israel
New York, New York, 10003

Other trials in United States

About this study

Official title: To Characterize the Acute and Short-term Effects of Cannabidiol (CBD) Administration on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans

Read the detailed description

There has been an epidemic rise in heroin abuse and overdose in recent years. Of the more than one million people suffering today from opiate dependency, less than a quarter of such individuals receive treatment. Pharmacotherapeutic approaches traditionally have targeted mu opioid receptors since heroin and its metabolites bind with highest affinity to this receptor subtype. Although such treatment strategies have improved substance abuse outcomes, they do not effectively block opiate craving and thus are still associated with high rates of relapse. Using a strategy of indirectly regulating neural systems to modulate opioid-related behavior, our preclinical rodent studies consistently demonstrated that cannabidiol (CBD), a nonpsychoactive component of cannabis, specifically inhibited cue-induced heroin-seeking behavior. CBD's selective effect on drug-seeking behavior was pronounced after 24 hrs and endured even two weeks after the last drug administration following short-term CBD exposure. The fact that drug craving is generally triggered by exposure to conditioned cues suggests that CBD might be an effective treatment for heroin craving, specially given its protracted impact on behavior. CBD has already been shown in Phase I of our study and in various clinical studies to be well tolerated with a wide safety margin in human subjects. CBD thus represents a strong candidate for the development as a potential therapeutic agent in humans for opioid craving and relapse prevention. Preliminary pilot study showed CBD decreased craving. It is the goal of the current study to more fully characterize the effects of CBD administration on cue-induced craving in drug-abstinent heroin-dependent subjects using a random double blind design during a post-acute (greater than 6 days since last use) heroin withdrawal period. Study participants will be administered CBD during 3 test sessions and studied for the effects on cue-induced craving during those sessions as well as one week after the final CBD administration on the final test day (session 4).

Conditions: Opiate Addiction
Being tested: CBD 400 mg, CBD 800 mg, Control (placebo)
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBD 400 mgDrug
Also called CBD
Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
CBD 800 mgDrug
Also called CBD
Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
Control (placebo)Drug
Also called CBD
Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study

Study groups in NCT02539823
Study group	Role	What they receive
Control	Placebo comparator	Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties Receives: Drug: Control (placebo)
CBD 400mg	Experimental	Subjects will receive 400mg of cannabidiol Receives: Drug: CBD 400 mg
CBD 800mg	Experimental	Subjects will receive 800 mg of cannabidiol Receives: Drug: CBD 800 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions in the clinic will be measured. Note, cue sessions occur consecutively in the same test day. In this way, changes in craving from baseline (pre-cue to post-cue within each test day), as well as changes in cue-induced craving over the short-term (test day 1 through test day 4 a week later) will be monitored and measured. VASC scale ranges from 0 for "Not Craving at All" to 10 for "Extremely Craving."
Measured: VASC: test day I, II and IV - at arrival, baseline for cue 1 and 2, post-cue 1 and 2, before discharge (approximately 2.5 hours from session start on average); test day III: at arrival and discharge (approx. 2.5 hours from session start on average)
Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)
Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test day 1 through test day 4 (1 week later). Each item is scored on a scale ranging from 1 for "Strongly Disagree" to 7 for "Strongly Agree." Sum of all 14 items are scored and added. Mean scores reported below. Total Score Range: 14 (less cravings) - 98 (more cravings).
Measured: HCQ: once in clinic pre-dose at each test day, and once at home after each test day.

Secondary outcomes (1)

Vital Signs
Blood pressure (in mmHg), heart rate (in beats/min), temperature (in degrees Fahrenheit), respiratory rate (in breaths/min), and O2 saturation and pain will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points. Note, cue sessions occur consecutively in the same test day.
Results reported below are responses from baseline following exposure to neutral and heroin-associated cues in Session 1 in subjects with CBD or placebo administration.
Measured: Pre-placebo/drug, -60 min pre-cue, -40 min pre-cue, -20 min pre-cue, cue (time 0), 15 min post-cue, 35 min post-cue, 50 min post-cue, 65 min post-cue, 85 min post-cue

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201524 May 2017

First posted3 Sep 2015 (estimated)
Study startSep 2015
Primary completion24 May 2017
Study completion24 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opiate AddictionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02539823
Sponsor's protocol ID: MSBI HSM# 087-14
Status last verified: Aug 2022
First submitted: 25 Aug 2015
Last updated: 1 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hurd YL, Spriggs S, Alishayev J, Winkel G, Gurgov K, Kudrich C, Oprescu AM, Salsitz E. Cannabidiol for the Reduction of Cue-Induced Craving and Anxiety in Drug-Abstinent Individuals With Heroin Use Disorder: A Double-Blind Randomized Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):911-922. doi: 10.1176/appi.ajp.2019.18101191. Epub 2019 May 21.
PubMed 31109198

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Characterize the Acute and Short-term Effects of Cannabidiol (CBD) Administration on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans
ClinicalTrials.gov ID: NCT02539823
Acronym / sponsor ID: MSBI HSM# 087-14
Conditions: Opiate Addiction
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Hurd,Yasmin, Ph.D.
Collaborators: Jazz Pharmaceuticals
Study start: Sep 2015
Primary completion: 24 May 2017 (actual)
Study completion: 24 May 2017 (actual)
First posted: 3 Sep 2015 (estimated)
Results: Posted 1 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Control	Placebo comparator	Drug: Control (placebo)Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
CBD 400mg	Experimental	Drug: CBD 400 mgSubjects will receive 400mg of cannabidiol
CBD 800mg	Experimental	Drug: CBD 800 mgSubjects will receive 800 mg of cannabidiol

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Must be between 21 and 65 years old
Must have an opiate dependence that meets criteria set in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Structured Clinical Interview for DSM (SCID-V) over the last three months
No opioid use in the past 7 days (will be verified via urine drug screen and opiate metabolite test)

Key exclusion criteria (12 listed)

Using any psychoactive drug (other than nicotine) any time up to test session 3
Having a diagnosis of drug dependence (except for heroin or nicotine) in the past 3 months, based on the SCID-V interview criteria
Being maintained on methadone or buprenorphine, or taking opioid antagonists such as naltrexone
Having a positive a drug screen
Showing signs of acute heroin withdrawal symptoms

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBD 400 mgAlso: CBDSubjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions	Drug	CBD 400mg
CBD 800 mgAlso: CBDSubjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions	Drug	CBD 800mg
Control (placebo)Also: CBDSubjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study	Drug	Control

Primary outcome

Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
Time frame: VASC: test day I, II and IV - at arrival, baseline for cue 1 and 2, post-cue 1 and 2, before discharge (approximately 2.5 hours from session start on average); test day III: at arrival and discharge (approx. 2.5 hours from session start on average)
The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions in the clinic will be measured. Note, cue sessions occur consecutively in the same test day. In this way, changes in craving from baseline (pre-cue to post-cue within each test day), as well as changes in cue-induced craving over the short-term (test day 1 through test day 4 a week later) will be monitored and measured. VASC scale ranges from 0 for "Not Craving at All" to 10 for "Extremely Craving."
Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)
Time frame: HCQ: once in clinic pre-dose at each test day, and once at home after each test day.
Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test day 1 through test day 4 (1 week later). Each item is scored on a scale ranging from 1 for "Strongly Disagree" to 7 for "Strongly Agree." Sum of all 14 items are scored and added. Mean scores reported below. Total Score Range: 14 (less cravings) - 98 (more cravings).

1 secondary outcome

Vital Signs
Time frame: Pre-placebo/drug, -60 min pre-cue, -40 min pre-cue, -20 min pre-cue, cue (time 0), 15 min post-cue, 35 min post-cue, 50 min post-cue, 65 min post-cue, 85 min post-cue

Results and safety

Results posted to the registry on 1 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	15	15
CBD 400mg	14	14
CBD 800mg	13	13

Primary outcome: Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)

Time frame: VASC: test day I, II and IV - at arrival, baseline for cue 1 and 2, post-cue 1 and 2, before discharge (approximately 2.5 hours from session start on average); test day III: at arrival and discharge (approx. 2.5 hours from session start on average). Mean (Standard Error). Unit: units on a scale

Measure	Control n = 15	CBD 400mg n = 14	CBD 800mg n = 13
First Baseline (before cue video) Session 1	1.40 (1.765)	1.64 (1.946)	2.31 (2.057)
First Baseline (before cue video) Session 2	1.33 (1.33)	1.07 (1.141)	1.46 (2.106)
First Baseline (before cue video) Session 4	.53 (.53)	.79 (1.051)	1.58 (2.429)
First Post Cue Session 1	2.53 (3.091)	2.21 (1.929)	2.69 (1.932)
First Post Cue Session 2	2.00 (2.646)	1.36 (1.336)	1.85 (2.512)
First Post Cue Session 4	1.27 (1.710)	1.07 (1.141)	1.67 (2.498)
Second Base Line (before cue video) Session 1	1.47 (2.326)	1.43 (1.950)	1.77 (1.878)
Second Base Line (before cue video) Session 2	1.00 (1.363)	1.00 (1.109)	1.62 (2.022)

Primary outcome: Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)

Time frame: HCQ: once in clinic pre-dose at each test day, and once at home after each test day.. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Control n = 15	CBD 400mg n = 14	CBD 800mg n = 13
Session 1: Pre Drug/Placebo (Baseline)	60.13 (56.36 to 63.91)	59.33 (53.87 to 64.80)	59.75 (54.72 to 64.78)
Session 1: Post (At Home)	53.20 (47.86 to 58.54)	50.00 (43.23 to 56.77)	53.42 (46.23 to 60.60)
Session 2: Pre Drug/Placebo (Day 2 Baseline)	53.40 (49.88 to 56.92)	52.00 (45.33 to 58.67)	51.17 (45.13 to 57.20)
Session 2 Post (At Home)	54.80 (49.70 to 59.90)	49.47 (42.32 to 56.61)	54.92 (45.50 to 64.33)
Session 3: Pre Drug/Placebo (Day 3 Baseline)	52.67 (46.84 to 58.49)	50.87 (43.65 to 58.08)	53.92 (45.79 to 62.04)
Session 3 Post (At Home)	52.21 (48.92 to 55.51)	50.20 (43.79 to 56.61)	55.40 (47.88 to 63.12)
Session 4: Drug/Placebo (Day 4 Baseline)	53.53 (50.11 to 56.95)	49.67 (42.83 to 56.50)	52.09 (41.81 to 62.37)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected during the course of study participation, approx. 2 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 15 (0%)	3 of 15 (20%)	0 of 15
CBD 400mg	0 of 14 (0%)	4 of 14 (28.6%)	0 of 14
CBD 800mg	0 of 13 (0%)	5 of 13 (38.5%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31109198Hurd YL, Spriggs S, Alishayev J, Winkel G, Gurgov K, Kudrich C, Oprescu AM, Salsitz E. Cannabidiol for the Reduction of Cue-Induced Craving and Anxiety in Drug-Abstinent Individuals With Heroin Use Disorder: A Double-Blind Randomized Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):911-922. doi: 10.1176/appi.ajp.2019.18101191. Epub 2019 May 21.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yasmin Hurd, PhD principal investigator

Mount Sinai Health System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CBD 400 mg and CBD 800 mg in people with Opiate Addiction, run by Hurd,Yasmin, Ph.D. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC) (time frame: VASC: test day I, II and IV - at arrival, baseline for cue 1 and 2, post-cue 1 and 2, before discharge (approximately 2.5 hours from session start on average); test day III: at arrival and discharge (approx. 2.5 hours from session start on average)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02539823, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.