Effects of Cannabidiol on Marijuana-seeking in Humans

NCT02777502 | Completed DMC

• 1 other identifier: CBD-1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed study is to investigate the effectiveness of cannabidiol for reducing marijuana seeking in non-treatment seeking volunteers. Cannabidiol is a cannabinoid (similar to cannabis, or marijuana) present in marijuana that alters some of the effects of marijuana. Assess the ability of acute smoked CBD pretreatment to reduce marijuana-seeking behavior and increase price-elasticity of marijuana demand.

Conditions

Marijuana Abuse

Outcome Measures

Primary Outcomes (13)

• Marijuana Craving Visual Analog Scale (VAS) (Self-report measure)

  Change is being assessed. Marijuana Craving VAS administered at baseline 0900. Administered at 0945 and every 15 minutes until 1045, then every 30 minutes until 1245. At 1330 administered every 15 minutes until 1430, then every 30 minutes until 1630.

• Marijuana Craving Questionnaire (Self-report measure)

  Change is being assessed. Marijuana Craving Quest. administered at baseline 0900. Administered at 0945 and every 15 minutes until 1045, then every 30 minutes until 1245. At 1330 administered every 15 minutes until 1430, then every 30 minutes until 1630.

• Marijuana Rating Form (Self-report measure)

  Change is being assessed. Marijuana Rating Form administered at baseline 0900. Administered at 0945 and every 15 minutes until 1045, then every 30 minutes until 1245. At 1330 administered every 15 minutes until 1430, then every 30 minutes until 1630.

• Subjective Effects Scale Visual Analog Scale (VAS) (Self-report measure)

  Change is being assessed. Subjective Effects Scale administered at baseline 0900. Administered at 0945 and every 15 minutes until 1045, then every 30 minutes until 1245. At 1330 administered every 15 minutes until 1430, then every 30 minutes until 1630.

• State-Trait Anxiety Inventory (Self-report measure)

  Change is being assessed. State-Trait Anxiety administered at baseline 0900. Administered at 0945 and every 15 minutes until 1045, then every 30 minutes until 1245. At 1330 administered every 15 minutes until 1430, then every 30 minutes until 1630.

• Systolic blood pressure (physiological effects)

  Examine whether acute smoked cannabidiol (CBD) attenuates physiological (cardiovascular) effects of marijuana.

  Change is being assessed. Systolic blood pressure measured at baseline 0900. Then measured at 0945 and every 15 minutes until 1045, then every 30 minutes until 1245. At 1330 measured every 15 minutes until 1430, then every 30 minutes until 1630.

• Diastolic blood pressure (physiological effects)

  Examine whether acute smoked cannabidiol (CBD) attenuates physiological (cardiovascular) effects of marijuana.

  Change is being assessed. Diastolic blood pressure measured at baseline 0900. Then measured at 0945 and every 15 minutes until 1045, then every 30 minutes until 1245. At 1330 measured every 15 minutes until 1430, then every 30 minutes until 1630.

• Heart rate (physiological effects)

  Examine whether acute smoked cannabidiol (CBD) attenuates physiological (cardiovascular) effects of marijuana.

  Change is being assessed. Heart rate measured at baseline 0900. Then measured at 0945 and every 15 minutes until 1045, then every 30 minutes until 1245. At 1330 measured every 15 minutes until 1430, then every 30 minutes until 1630.

• Core-body temperature (physiological effects)

  Examine whether acute smoked cannabidiol (CBD) attenuates physiological (cardiovascular) effects of marijuana.

  Change is being assessed. Core-body temperature measured at baseline 0900. Then measured at 0945 and every 15 minutes until 1045, then every 30 minutes until 1245. At 1330 measured every 15 minutes until 1430, then every 30 minutes until 1630.

• Derive peak concentration (Cmax)

  Cannabidiol Pharmacokinetics

  Change is being assessed.Six samples will be taken in each session: prior to the Cannabidiol dose (-15 min), and at 0.5, 1, 2, 3, and 4 h post-Cannabidiol

• Time to peak (Tmax) and 6-hr area under the curve (AUC) measures

  Cannabidiol Pharmacokinetics

  Change is being assessed.Six samples will be taken in each session: prior to the Cannabidiol dose (-15 min), and at 0.5, 1, 2, 3, and 4 h post-Cannabidiol

• Safety of Cannabidiol (CBD) for reducing marijuana seeking in non-treatment seeking volunteers with Cannabis use Disorders

  Measure drug-seeking behavior using a computerized (laptop) choice, progressive ratio procedure which allows participant to choose between marijuana puffs or money.

  Change is being assessed throughout three 30-minute computer procedures that will be conducted during each of the three choice sessions. The three choice sessions will be conducted over two weeks, with each session day separated by at least 2 days.

• Efficacy of Cannabidiol (CBD) for reducing marijuana seeking in non-treatment seeking volunteers with Cannabis use Disorders

  Measure drug-seeking behavior using a computerized (laptop) choice, progressive ratio procedure which allows participants to choose between marijuana puffs or money.

  Change is being assessed throughout three 30-minute computer procedures that will be conducted during each of the three choice sessions. The three choice sessions will be conducted over two weeks, with each session day separated by at least 2 days.

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Marijuana Dependent Participants

You may qualify if:

• Participants will be males and females aged 21-45 yrs.
• Must be in generally good health.
• Volunteers may meet DSM-5 criteria for current Cannabis Use Disorder but not currently be in treatment or seeking treatment for their substance use problems.

You may not qualify if:

• Neurologic disease: structural brain abnormalities (e.g., neoplasms), cerebrovascular disease, seizures, infectious disease, history of other neurological diseases, or head trauma resulting in unconsciousness.
• Cardiovascular disease: edema, chest pain or palpitations on exertion or drug use, myocardial infarction, systolic blood pressure greater than 160 or less than 95 mmHg, or diastolic pressure greater than 95 mmHg.
• Pulmonary disease: obstructive pulmonary disease, apnea, cor pulmonale, tuberculosis, dyspnea, orthopnea, or tachypnea (\> 24 breaths per minute). Current diagnosis of or treatment for asthma. History of asthma may be allowed, per the study physician's discretion.
• Systemic disease: e.g., endocrinopathies, renal or hepatic failure, active hepatitis (liver function tests \> 3x normal cutoff), myxedema, hypothyroidism, adrenocortical insufficiency, Cushing syndrome, chronic GI disease, AIDS or any other autoimmune disease involving the CNS.
• Current substance use disorders other than Cannabis or Nicotine Use Disorder.
• Cognitively impairment as indicated by an estimated IQ of lower than 85. Individuals unable to give voluntary informed consent will not be enrolled. They can be neither intoxicated nor undergoing withdrawal at the time of screening and consent.
• Recent experimental participation (within past month).
• Pregnancy or lactation. Females who are heterosexually active and not using (self-report) medically approved birth control measures (e.g., sterilization, tubal ligation, birth control pills, abstinence, intrauterine device, barrier method, cervical cap combined with a spermicide) are not eligible. Women who are breastfeeding will be excluded.
• Individuals currently in, intending to seek, or court mandated for substance abuse treatment will be excluded. Finally, participants may be withdrawn from study if they do not comply with the study protocol, test positive for drugs of abuse other than marijuana on the routine urine screen or decide not to participate in the study.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Tolan Park Medical Building

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

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

Study Officials

• Leslie Lundahl, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: May 19, 2016
• Study Start: January 1, 2016
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)