Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans
Condition: Opiate Addiction
MeSH terms: Opioid-Related Disorders
Intervention: CBD 400 mg; CBD 800 mg; Control (placebo)
Intervention description: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions; Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions; Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  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])

          -  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)