Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans

NCT01605539 | Completed Phase 2 Results DMC

• 2 other identifiers: R21 DA027781(2)R21DA027781
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. The development of a targeted treatment for opioid relapse would be of tremendous medical and public health value.

Conditions

Opiate Addiction

Outcome Measures

Primary Outcomes (2)

• Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - 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 and neutral cue sessions in the clinic will be measured. In this way, changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) within each test visit) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving). \*\*For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. The same questionnaires will be administered immediately following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test

  VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

• Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - 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 visit 1 through test visit 4. Scale: 1 (strongly disagree) - 7 (strongly agree). Total Score Range: 14 (less cravings) - 98 (more cravings). \*\* The baseline measure for this outcome will be measured at the beginning of test session I prior to the administration of CBD/Placebo. Test measures will be taken approximately 6 hours following each dose for test sessions I, II and III. The final measure will be taken at test session IV, at the beginning of the session.

  Test I and II: Change from pre-dose to approx. 6 hours post-dose; Change from pre-dose test visit I to pre-cue test visit IV

Secondary Outcomes (7)

• Vital Signs - Blood Pressure

  Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

• Visual Analog Scale for Anxiety (VASA)

  Test visit I, II and IV: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

• The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data

  Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

• The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data

  Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

• Vital Signs - Heart Rate

  Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

Study Arms (3)

Control

PLACEBO COMPARATOR

Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties.

Drug: Control

Cannabidiol 400

EXPERIMENTAL

Subjects in Arm Cannabidiol 400 will receive 400 mg of cannabidiol

Drug: Cannabidiol 400

Cannabidiol 800

EXPERIMENTAL

Subjects in Arm Cannabidiol 800 will receive 800mg of cannabidiol

Drug: Cannabidiol 800

Interventions

Cannabidiol 400 DRUG

Subjects in Arm CBD 400 will receive 400mg of Cannabidiol in each of the three test sessions

Also known as: CBD

Cannabidiol 400

Cannabidiol 800 DRUG

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

Also known as: CBD

Cannabidiol 800

Control DRUG

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

Also known as: CBD

Control

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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-IV 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-IV (examined using the Mini International Neuropsychiatric Interview \[MINI\])
• 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)

Sponsors & Collaborators

• Hurd,Yasmin, Ph.D.: lead

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Yasmin Hurd, PhD
• Organization: Icahn School of Medicine at Mount Sinai

yasmin.hurd@mssm.edu

212-824-9314

Study Officials

• Yasmin Hurd, Ph.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 25, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 11, 2020
• Results First Posted: November 28, 2016

Record last verified: 2020-07

Locations

US (1)