Marijuana AbuseNCT02777502
Effects of Cannabidiol on Marijuana-seeking in Humans
An observational study of Marijuana Abuse, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Marijuana Abuse
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Marijuana Dependent Participants
Who may be able to join
- 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.
- An observed, temperature-tested urine specimen must test positive for THC so that inclusion is not solely based on self-report.
Who cannot join
- Psychiatric illness other than Cannabis or Nicotine Use Disorder. Also exclusionary is a history or suspicion of psychosis or indication of behavior not conducive to compliance with the study protocol.
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tolan Park Medical Building
Detroit, Michigan, 48201
About this study
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.
Read the detailed description
Participants will be asked to participate in a total of three choice sessions over two weeks with each session day separated by at least two days. Each session day will last approximately 8 hours.
During each study session participants will be asked to smoke a cigarette. Participants will be asked to smoke from a marijuana cigarette. These cigarettes may contain cannabidiol or they may not (placebo).
Participants will be asked to answer questions about how the drugs make them feel. Vitals signs (blood pressure, heart rate, and oxygen saturation) will be measured using a non-invasive (external) vitals monitor.
Six samples will be taken in each of the three sessions. Blood samples will be obtained via butterfly catheter placed in a vein.
Participants will be asked to remain in the laboratory until all marijuana-related subjective and physiological effects have returned to the original levels recorded this morning before they smoked the first marijuana cigarette.
- Conditions
- Marijuana Abuse
- Medical subject headings
- Marijuana Abuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana Craving Visual Analog Scale (VAS) (Self-report measure)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start1 Jan 2016
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana AbuseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Lundahl, Wayne State University
- Investigators
- Leslie Lundahl, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777502
- Sponsor's protocol ID
- CBD-1
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2016
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabidiol on Marijuana-seeking in Humans
- ClinicalTrials.gov ID
- NCT02777502
- Acronym / sponsor ID
- CBD-1
- Conditions
- Marijuana Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be asked to participate in a total of three choice sessions over two weeks with each session day separated by at least two days. Each session day will last approximately 8 hours.
During each study session participants will be asked to smoke a cigarette. Participants will be asked to smoke from a marijuana cigarette. These cigarettes may contain cannabidiol or they may not (placebo).
Participants will be asked to answer questions about how the drugs make them feel. Vitals signs (blood pressure, heart rate, and oxygen saturation) will be measured using a non-invasive (external) vitals monitor.
Six samples will be taken in each of the three sessions. Blood samples will be obtained via butterfly catheter placed in a vein.
Participants will be asked to remain in the laboratory until all marijuana-related subjective and physiological effects have returned to the original levels recorded this morning before they smoked the first marijuana cigarette.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Marijuana Dependent Participants
Key inclusion criteria (4 listed)
- 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.
- An observed, temperature-tested urine specimen must test positive for THC so that inclusion is not solely based on self-report.
Key exclusion criteria (10 listed)
- Psychiatric illness other than Cannabis or Nicotine Use Disorder. Also exclusionary is a history or suspicion of psychosis or indication of behavior not conducive to compliance with the study protocol.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Marijuana Craving Visual Analog Scale (VAS) (Self-report measure)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Examine whether acute smoked cannabidiol (CBD) attenuates physiological (cardiovascular) effects of marijuana.
Diastolic blood pressure (physiological effects)
Time frame: 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.
Examine whether acute smoked cannabidiol (CBD) attenuates physiological (cardiovascular) effects of marijuana.
Heart rate (physiological effects)
Time frame: 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.
Examine whether acute smoked cannabidiol (CBD) attenuates physiological (cardiovascular) effects of marijuana.
Core-body temperature (physiological effects)
Time frame: 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.
Examine whether acute smoked cannabidiol (CBD) attenuates physiological (cardiovascular) effects of marijuana.
Derive peak concentration (Cmax)
Time frame: 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
Cannabidiol Pharmacokinetics
Time to peak (Tmax) and 6-hr area under the curve (AUC) measures
Time frame: 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
Cannabidiol Pharmacokinetics
Safety of Cannabidiol (CBD) for reducing marijuana seeking in non-treatment seeking volunteers with Cannabis use Disorders
Time frame: 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.
Measure drug-seeking behavior using a computerized (laptop) choice, progressive ratio procedure which allows participant to choose between marijuana puffs or money.
Efficacy of Cannabidiol (CBD) for reducing marijuana seeking in non-treatment seeking volunteers with Cannabis use Disorders
Time frame: 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.
Measure drug-seeking behavior using a computerized (laptop) choice, progressive ratio procedure which allows participants to choose between marijuana puffs or money.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Marijuana Abuse
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
Cannabis Dependence, Harmful Use
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.
Leslie Lundahl, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marijuana Abuse, run by Wayne State University 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 4 inclusion and 10 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 25 Feb 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Marijuana Craving Visual Analog Scale (VAS) (Self-report measure) (time frame: 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.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2022.