Cannabis UsePhase 1NCT02177513
Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics
A Phase 1 study testing 6.9% cannabis oral in people with Cannabis Use, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions, attention, and behavior after they take marijuana in different ways. They want to learn better ways to detect drugs in a person s body They also want to know how long marijuana can be found in blood, urine, saliva, and… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- What is being tested?
- 6.9% cannabis oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2014to 27 Apr 2016
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 50 years of age;
- Cannabis consumption with a minimum frequency of at least twice per month during the three months prior to the study and average frequency of cannabis smoking of less than three times per week (occasional cannabis smoker) in the past 3 months or at least an average of five times per week (frequent cannabis smoker) in the past 3 months;
- A positive urine cannabinoid screen if in the frequent cannabis smoker group;
- Peripheral veins suitable for repeated venipuncture and/or placement of an intravenous catheter, as assessed by a physician s assistant, nurse, or physician;
- Blood pressure (BP) and heart rate (HR) at or below the following values while sitting after five min rest: systolic BP (SBP) 140 mm Hg, diastolic BP (DBP) 90 mm Hg, heart rate (HR) 100 bpm;
- ECG and three-minute rhythm strip without clinically relevant abnormalities;
- Women with reproductive potential must use a medically acceptable form of contraception for the duration of the study. Medically acceptable forms of contraception include: oral contraceptive, intrauterine device (IUD), depot hormonal preparation (ring, injection implant), or a barrier method of contraception such as a diaphragm, sponge with spermicide, or a condom. Abstinence is an alternative lifestyle and subjects practicing abstinence may be included in the study.
- Must be able to safely suspend use of CNS depressant, anticholinergic, and/or sympathomimetic medications before study dosing. Length of medication suspension will be equal to 3 half-lives of the medication in use.
Who cannot join
- Current physical dependence on any drug other than cannabis, caffeine, or nicotine;
- Currently using cannabis for medical purposes under the explicit recommendation of a physician providing medical care;
- History or presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests , that might put the subject at increased risk of adverse events such as history of psychotic disorder, clinically significant mood and/or anxiety disorder, diabetes, liver, renal or cardiovascular disease;
- Liver enzymes greater than or equal to 2 times upper normal limit and/or clinical signs/symptoms consistent with liver disease including but not limited to nausea, vomiting, jaundice, itching, abdominal pain, and swelling;
- History of clinically significant adverse events associated with cannabis intoxication such as severe anxiety and panic, paranoia and psychosis, sustained tachycardia, or severe hypotension;
- Donation of more than 450 mL blood within 8 weeks of study treatment phase;
Show all 11Show fewer
- Hemoglobin less than 12.0 g/dL and/or clinical signs/symptoms consistent with anemia including but not limited to fatigue, tachycardia, shortness of breath, and dizziness;
- If female, pregnant or nursing;
- Currently interested in or participating in drug abuse treatment, or participated in drug abuse treatment within 90 days preceding study enrollment;
- History of food allergy or sensitivity to gluten, dairy, egg, soy, and/or chocolate.
- Any form of color blindness
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Background:
- Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions, attention, and behavior after they take marijuana in different ways. They want to learn better ways to detect drugs in a person s body They also want to know how long marijuana can be found in blood, urine, saliva, and breath.
Read more
Objectives:
- To learn how people respond to delta-9-tetrahydrocannabinol (THC, a marijuana component) and how their bodies handle it after it is given in different ways.
Eligibility:
- Adults age 18 50 who use marijuana.
Design:
- Participants are screened under another NIDA protocol.
- This study involves up to 6 visits to NIDA.
- At the first visit, participants will practice the tasks and tests they will do at their dosing sessions. They will learn how to give breath and saliva samples.
- Dosing sessions 1 4 will last 3 5 days each. All participants will be admitted to a research clinic the night before these sessions. Some participants can stay at the clinic and some must go home between sessions.
- At each session, participants will eat a brownie with placebo or marijuana. Then they will smoke a placebo or marijuana cigarette. Some will inhale placebo or marijuana after it is vaporized.
- Throughout the sessions:
- Participants will give urine, saliva, and breath samples. Their blood will be taken with a tube in a vein and finger pricks. Their vital signs will be checked.
- Participants will answer questionnaires and take thinking tests. They will also take tests that assess eye movement, balance, and time estimation.
- Participants may have a 5th dosing session. They will eat a marijuana brownie and have the above tests and samples.
Read the detailed description
Objectives
Cannabinoids are most commonly administered via smoking. Oral consumption in medications, teas, oils, or food also is widely utilized. Additionally, cannabis vaporization followed by inhalation for medical and illicit administration is common. Differences in cannabis pharmacodynamics and pharmacokinetics between these three administration routes and in occasional and frequent cannabis smokers are not thoroughly characterized. This study evaluates cannabis pharmacodynamics and pharmacokinetics in occasional and frequent smokers after smoked, vaporized, and oral cannabis administration.
<TAB>
Study Population
Up to 80 healthy cannabis smokers, aged 18-50, without a history of adverse reactions to cannabis will be recruited. For dosing sessions 1-4, ten occasional smokers (smoking frequency greater than or equal to 2 times/month but <3 times/week) and ten frequent smokers (smoking frequency generally greater than or equal to 5times/week) are required. For the optional 5th session, 8-20 participants (regardless of smoking history) are required.
<TAB>
Study Design
Occasional and frequent cannabis smokers are recruited to participate. Prior to dosing sessions, there is a training visit for all study procedures. Sessions 1-4 are 3 and 4 days each for occasional and frequent cannabis smokers, respectively, and the study design is double blind, double dummy, randomized, crossover, and placebo-controlled. In each session, participants will consume a placebo or active oral (baked in a brownie) cannabis (6.9% 9-tetrahydrocannabinol [THC]) dose followed by either placebo or active smoked or vaporized cannabis. Only one active dose will be administered in each dosing session. Whole blood, oral fluid, urine, dried blood spots, and breath are collected throughout all sessions. Due to the large THC body burden stored in the tissues, we will collect biological specimens for a longer period in frequent cannabis smokers than for occasional cannabis smokers. An optional 5th dosing session will be offered in which participants receive a single oral cannabis dose for pharmacokinetic monitoring. The placebo cannabis plant material has a low THC concentration. As we are expecting that the active brownie dose might result in low THC oral fluid contamination, it is necessary to have an active brownie THC dose that is not followed by placebo vaporizer or smoked cannabis. Occasional smokers may stay or be discharged between sessions, including between the 4th and optional 5th dosing session, but dosing must not exceed self-reported intake frequency. Frequent smokers must be discharged for at least 72 h between dosing sessions 1-4, and must stay on the unit at the end of session 4 for session 5 if they choose to participate. The difference between requirements for occasional and frequent smokers to participate in the optional 5th dose is due to the potential confound of low THC concentrations in frequent smokers that might not permit the detection of low THC concentrations after consumption of a low oral THC dose. Occasional cannabis smokers will reside on the closed research unit for approximately 72 h for dosing sessions 1-4, and for approximately 66 h for dosing session 5. Frequent cannabis smokers will reside on the closed research unit for approximately 90 h for dosing sessions 1-3 (and 4 if not participating in optional session 5). If a frequent smoker chooses to participate in dosing session 5, they will remain on the unit for approximately 162 h for sessions 4 and 5. Participants will complete a battery of subjective, objective, and neurocognitive tests before and after dosing. Subjective effects are assessed with visual analog scales. Objective measurements include physiological measurements, expired carbon monoxide, reddening of the conjunctivae and tests measuring psychomotor skills and cognitive functions.
<TAB>
Outcome Parameters
Primary outcome measures include subjective and objective assessments, performance on neurocognitive tasks, and cannabinoid concentrations in whole blood, oral fluid, urine, dried blood spots, and breath. Correlations between cannabinoid concentrations in whole blood, dried blood spots, oral fluid, and breath will be investigated, the Oral Fluid Working Group for the Partnership for Clean Competition oral fluid screening algorithm will be evaluated, and the pharmacokinetic profiles of alternative cannabinoids will be characterized. Secondary investigations include comparing cannabinoid stability in dried blood spots and whole blood, evaluating the World Anti-Doping Agency urine 11-nor-9-carboxy-THC decision limit, characterizing the performance of the Alere DDS2 on-site oral fluid screening device, and evaluating effects of acute cannabis administration on leptin and other appetitive peptides.<TAB>
- Conditions
- Cannabis Use
- Being tested
- Placebo + Placebo, Oral Cannabis + Placebo, Placebo + Inhaled Cannabis, Placebo + Smoked Cannabis, 6.9% cannabis oral
- Keywords
- Cannabis, Pharmacodynamics, Marijuana, Cannabinoids, Vaporized
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo + PlaceboDrug
Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette followed by smoking or inhaling (after vaporization) the equivalent of one placebo (0.001% THC) cigarette.
Oral Cannabis + PlaceboDrug
Participants will consume a brownie containing the equivalent of one active (6.9% THC) cannabis cigarette followed by either smoking or inhaling (after vaporization) the equivalent of one placebo (0.001% THC) cigarette.
Placebo + Inhaled CannabisDrug
Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette
Placebo + Smoked CannabisDrug
Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette followed by smoking the equivalent of one active (6.9% THC) cigarette.
6.9% cannabis oralDrug
Participants will consume a brownie containing the equivalent of one active (6.91% THC) cannabis cigarette.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Placebo + Smoked Cannabis |
| 2 | Active comparator | Not described Receives: Drug: Placebo + Inhaled Cannabis |
| 3 | Active comparator | Not described Receives: Drug: Oral Cannabis + Placebo |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo + Placebo |
| 5 | Active comparator | Not described Receives: Drug: 6.9% cannabis oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis' pharmacodynamic effects
Measured: Multiple times daily
Cannabis' pharmacokinetic profiles
Measured: Multiple times daily
Pharmacokinetic/Dynamic Modelling
Measured: Once
Cannabis oral fluid cutoff evaluation
Measured: Once
Secondary outcomes (6)
Cannabinoid stability in dried blood
Measured: Multiple times
Pharmacokinetic/Dynamic Modelling
Measured: Multiple times
Cannabinoid stability in oral fluid
Measured: Multiple times
Cannabis' effects on appetitive peptides
Measured: Multiple times daily
Cannabis urine cutoff evaluation
Measured: Once
Compare on-site oral fluid devices
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study start14 Jun 2014
- Primary completion27 Apr 2016
- Study completion27 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marilyn Huestis, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177513
- Sponsor's protocol ID
- 999914135
- Other IDs
- 14-DA-N135
- Status last verified
- 27 Apr 2016
- First submitted
- 24 Jun 2014
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Vega WA, Aguilar-Gaxiola S, Andrade L, Bijl R, Borges G, Caraveo-Anduaga JJ, DeWit DJ, Heeringa SG, Kessler RC, Kolody B, Merikangas KR, Molnar BE, Walters EE, Warner LA, Wittchen HU. Prevalence and age of onset for drug use in seven international sites: results from the international consortium of psychiatric epidemiology. Drug Alcohol Depend. 2002 Dec 1;68(3):285-97. doi: 10.1016/s0376-8716(02)00224-7.
PubMed 12393223Huestis MA. Pharmacokinetics and metabolism of the plant cannabinoids, delta9-tetrahydrocannabinol, cannabidiol and cannabinol. Handb Exp Pharmacol. 2005;(168):657-90. doi: 10.1007/3-540-26573-2_23.
PubMed 16596792Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.
PubMed 12648025Newmeyer MN, Swortwood MJ, Andersson M, Abulseoud OA, Scheidweiler KB, Huestis MA. Cannabis Edibles: Blood and Oral Fluid Cannabinoid Pharmacokinetics and Evaluation of Oral Fluid Screening Devices for Predicting Delta9-Tetrahydrocannabinol in Blood and Oral Fluid following Cannabis Brownie Administration. Clin Chem. 2017 Mar;63(3):647-662. doi: 10.1373/clinchem.2016.265371. Epub 2017 Feb 10.
PubMed 28188235Newmeyer MN, Swortwood MJ, Taylor ME, Abulseoud OA, Woodward TH, Huestis MA. Evaluation of divided attention psychophysical task performance and effects on pupil sizes following smoked, vaporized and oral cannabis administration. J Appl Toxicol. 2017 Aug;37(8):922-932. doi: 10.1002/jat.3440. Epub 2017 Jan 31.
PubMed 28138971Newmeyer MN, Swortwood MJ, Barnes AJ, Abulseoud OA, Scheidweiler KB, Huestis MA. Free and Glucuronide Whole Blood Cannabinoids' Pharmacokinetics after Controlled Smoked, Vaporized, and Oral Cannabis Administration in Frequent and Occasional Cannabis Users: Identification of Recent Cannabis Intake. Clin Chem. 2016 Dec;62(12):1579-1592. doi: 10.1373/clinchem.2016.263475. Epub 2016 Oct 10.
PubMed 27899456
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT02177513
- Acronym / sponsor ID
- 999914135
- Conditions
- Cannabis Use
- Keywords
- Cannabis, Pharmacodynamics, Marijuana, Cannabinoids, Vaporized
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 14 Jun 2014
- Primary completion
- 27 Apr 2016 (actual)
- Study completion
- 27 Apr 2016 (actual)
- First posted
- 27 Jun 2014 (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.
Background:
- Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions, attention, and behavior after they take marijuana in different ways. They want to learn better ways to detect drugs in a person s body They also want to know how long marijuana can be found in blood, urine, saliva, and breath.
Objectives:
- To learn how people respond to delta-9-tetrahydrocannabinol (THC, a marijuana component) and how their bodies handle it after it is given in different ways.
Eligibility:
- Adults age 18 50 who use marijuana.
Design:
- Participants are screened under another NIDA protocol.
- This study involves up to 6 visits to NIDA.
- At the first visit, participants will practice the tasks and tests they will do at their dosing sessions. They will learn how to give breath and saliva samples.
- Dosing sessions 1 4 will last 3 5 days each. All participants will be admitted to a research clinic the night before these sessions. Some participants can stay at the clinic and some must go home between sessions.
- At each session, participants will eat a brownie with placebo or marijuana. Then they will smoke a placebo or marijuana cigarette. Some will inhale placebo or marijuana after it is vaporized.
- Throughout the sessions:
- Participants will give urine, saliva, and breath samples. Their blood will be taken with a tube in a vein and finger pricks. Their vital signs will be checked.
- Participants will answer questionnaires and take thinking tests. They will also take tests that assess eye movement, balance, and time estimation.
- Participants may have a 5th dosing session. They will eat a marijuana brownie and have the above tests and samples.
Detailed description
Objectives
Cannabinoids are most commonly administered via smoking. Oral consumption in medications, teas, oils, or food also is widely utilized. Additionally, cannabis vaporization followed by inhalation for medical and illicit administration is common. Differences in cannabis pharmacodynamics and pharmacokinetics between these three administration routes and in occasional and frequent cannabis smokers are not thoroughly characterized. This study evaluates cannabis pharmacodynamics and pharmacokinetics in occasional and frequent smokers after smoked, vaporized, and oral cannabis administration.
<TAB>
Study Population
Up to 80 healthy cannabis smokers, aged 18-50, without a history of adverse reactions to cannabis will be recruited. For dosing sessions 1-4, ten occasional smokers (smoking frequency greater than or equal to 2 times/month but <3 times/week) and ten frequent smokers (smoking frequency generally greater than or equal to 5times/week) are required. For the optional 5th session, 8-20 participants (regardless of smoking history) are required.
<TAB>
Study Design
Occasional and frequent cannabis smokers are recruited to participate. Prior to dosing sessions, there is a training visit for all study procedures. Sessions 1-4 are 3 and 4 days each for occasional and frequent cannabis smokers, respectively, and the study design is double blind, double dummy, randomized, crossover, and placebo-controlled. In each session, participants will consume a placebo or active oral (baked in a brownie) cannabis (6.9% 9-tetrahydrocannabinol [THC]) dose followed by either placebo or active smoked or vaporized cannabis. Only one active dose will be administered in each dosing session. Whole blood, oral fluid, urine, dried blood spots, and breath are collected throughout all sessions. Due to the large THC body burden stored in the tissues, we will collect biological specimens for a longer period in frequent cannabis smokers than for occasional cannabis smokers. An optional 5th dosing session will be offered in which participants receive a single oral cannabis dose for pharmacokinetic monitoring. The placebo cannabis plant material has a low THC concentration. As we are expecting that the active brownie dose might result in low THC oral fluid contamination, it is necessary to have an active brownie THC dose that is not followed by placebo vaporizer or smoked cannabis. Occasional smokers may stay or be discharged between sessions, including between the 4th and optional 5th dosing session, but dosing must not exceed self-reported intake frequency. Frequent smokers must be discharged for at least 72 h between dosing sessions 1-4, and must stay on the unit at the end of session 4 for session 5 if they choose to participate. The difference between requirements for occasional and frequent smokers to participate in the optional 5th dose is due to the potential confound of low THC concentrations in frequent smokers that might not permit the detection of low THC concentrations after consumption of a low oral THC dose. Occasional cannabis smokers will reside on the closed research unit for approximately 72 h for dosing sessions 1-4, and for approximately 66 h for dosing session 5. Frequent cannabis smokers will reside on the closed research unit for approximately 90 h for dosing sessions 1-3 (and 4 if not participating in optional session 5). If a frequent smoker chooses to participate in dosing session 5, they will remain on the unit for approximately 162 h for sessions 4 and 5. Participants will complete a battery of subjective, objective, and neurocognitive tests before and after dosing. Subjective effects are assessed with visual analog scales. Objective measurements include physiological measurements, expired carbon monoxide, reddening of the conjunctivae and tests measuring psychomotor skills and cognitive functions.
<TAB>
Outcome Parameters
Primary outcome measures include subjective and objective assessments, performance on neurocognitive tasks, and cannabinoid concentrations in whole blood, oral fluid, urine, dried blood spots, and breath. Correlations between cannabinoid concentrations in whole blood, dried blood spots, oral fluid, and breath will be investigated, the Oral Fluid Working Group for the Partnership for Clean Competition oral fluid screening algorithm will be evaluated, and the pharmacokinetic profiles of alternative cannabinoids will be characterized. Secondary investigations include comparing cannabinoid stability in dried blood spots and whole blood, evaluating the World Anti-Doping Agency urine 11-nor-9-carboxy-THC decision limit, characterizing the performance of the Alere DDS2 on-site oral fluid screening device, and evaluating effects of acute cannabis administration on leptin and other appetitive peptides.<TAB>
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Placebo + Smoked Cannabis |
| 2 | Active comparator | Drug: Placebo + Inhaled Cannabis |
| 3 | Active comparator | Drug: Oral Cannabis + Placebo |
| 4 | Placebo comparator | Drug: Placebo + Placebo |
| 5 | Active comparator | Drug: 6.9% cannabis oral |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
Key exclusion criteria (11 listed)
- Current physical dependence on any drug other than cannabis, caffeine, or nicotine;
- Currently using cannabis for medical purposes under the explicit recommendation of a physician providing medical care;
- History or presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests , that might put the subject at increased risk of adverse events such as history of psychotic disorder, clinically significant mood and/or anxiety disorder, diabetes, liver, renal or cardiovascular disease;
- Liver enzymes greater than or equal to 2 times upper normal limit and/or clinical signs/symptoms consistent with liver disease including but not limited to nausea, vomiting, jaundice, itching, abdominal pain, and swelling;
- History of clinically significant adverse events associated with cannabis intoxication such as severe anxiety and panic, paranoia and psychosis, sustained tachycardia, or severe hypotension;
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 |
|---|---|---|
| Placebo + PlaceboParticipants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette followed by smoking or inhaling (after vaporization) the equivalent of one placebo (0.001% THC) cigarette. | Drug | 4 |
| Oral Cannabis + PlaceboParticipants will consume a brownie containing the equivalent of one active (6.9% THC) cannabis cigarette followed by either smoking or inhaling (after vaporization) the equivalent of one placebo (0.001% THC) cigarette. | Drug | 3 |
| Placebo + Inhaled CannabisParticipants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette | Drug | 2 |
| Placebo + Smoked CannabisParticipants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette followed by smoking the equivalent of one active (6.9% THC) cigarette. | Drug | 1 |
| 6.9% cannabis oralParticipants will consume a brownie containing the equivalent of one active (6.91% THC) cannabis cigarette. | Drug | 5 |
Primary outcome
Cannabis' pharmacodynamic effects
Time frame: Multiple times daily
Cannabis' pharmacokinetic profiles
Time frame: Multiple times daily
Pharmacokinetic/Dynamic Modelling
Time frame: Once
Cannabis oral fluid cutoff evaluation
Time frame: Once
6 secondary outcomes
Cannabinoid stability in dried blood
Time frame: Multiple times
Pharmacokinetic/Dynamic Modelling
Time frame: Multiple times
Cannabinoid stability in oral fluid
Time frame: Multiple times
Cannabis' effects on appetitive peptides
Time frame: Multiple times daily
Cannabis urine cutoff evaluation
Time frame: Once
Compare on-site oral fluid devices
Time frame: Once
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 16 Dec 2019.
- Background: PubMed 12393223Vega WA, Aguilar-Gaxiola S, Andrade L, Bijl R, Borges G, Caraveo-Anduaga JJ, DeWit DJ, Heeringa SG, Kessler RC, Kolody B, Merikangas KR, Molnar BE, Walters EE, Warner LA, Wittchen HU. Prevalence and age of onset for drug use in seven international sites: results from the international consortium of psychiatric epidemiology. Drug Alcohol Depend. 2002 Dec 1;68(3):285-97. doi: 10.1016/s0376-8716(02)00224-7.
- Background: PubMed 16596792Huestis MA. Pharmacokinetics and metabolism of the plant cannabinoids, delta9-tetrahydrocannabinol, cannabidiol and cannabinol. Handb Exp Pharmacol. 2005;(168):657-90. doi: 10.1007/3-540-26573-2_23.
- Background: PubMed 12648025Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.
- Derived from this study: PubMed 28188235Newmeyer MN, Swortwood MJ, Andersson M, Abulseoud OA, Scheidweiler KB, Huestis MA. Cannabis Edibles: Blood and Oral Fluid Cannabinoid Pharmacokinetics and Evaluation of Oral Fluid Screening Devices for Predicting Delta9-Tetrahydrocannabinol in Blood and Oral Fluid following Cannabis Brownie Administration. Clin Chem. 2017 Mar;63(3):647-662. doi: 10.1373/clinchem.2016.265371. Epub 2017 Feb 10.
- Derived from this study: PubMed 28138971Newmeyer MN, Swortwood MJ, Taylor ME, Abulseoud OA, Woodward TH, Huestis MA. Evaluation of divided attention psychophysical task performance and effects on pupil sizes following smoked, vaporized and oral cannabis administration. J Appl Toxicol. 2017 Aug;37(8):922-932. doi: 10.1002/jat.3440. Epub 2017 Jan 31.
- Derived from this study: PubMed 27899456Newmeyer MN, Swortwood MJ, Barnes AJ, Abulseoud OA, Scheidweiler KB, Huestis MA. Free and Glucuronide Whole Blood Cannabinoids' Pharmacokinetics after Controlled Smoked, Vaporized, and Oral Cannabis Administration in Frequent and Occasional Cannabis Users: Identification of Recent Cannabis Intake. Clin Chem. 2016 Dec;62(12):1579-1592. doi: 10.1373/clinchem.2016.263475. Epub 2016 Oct 10.
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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.
Marilyn Huestis, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 6.9% cannabis oral in people with Cannabis Use, run by National Institute on Drug Abuse (NIDA) 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 8 inclusion and 11 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 16 Dec 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cannabis' pharmacodynamic effects (time frame: Multiple times daily). The study lists 4 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 NCT02177513, which also lists 6 linked publications.
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 16 Dec 2019.