CannabisPhase 1NCT01037608
Effects of Sativex(Registered Trademark) and Oral THC on Attention, Affect, Working Memory, Reversal Learning, Physiology and Brain Activation
A Phase 1 study testing Sativex(Registered Trademark) and THC in people with Cannabis and Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: The therapeutic modalities of cannabis have received more research attention recently with the discovery of its ability to stimulate appetite and to provide pain and nausea relief in patients with AIDS, cancer, and multiple sclerosis, among other diseases. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis, Dependence, Cannabis Abuse
- What is being tested?
- Sativex(Registered Trademark) and THC
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2007to 12 Dec 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 45 years of age;
- Cannabis use with a minimum frequency of once in the last 90 days and maximum frequency of less than daily during the three months prior to study entry;
- 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;
- 12-lead standard ECG and three-minute rhythm strip without clinically relevant abnormalities;
- Peripheral veins suitable for repeated venipuncture and placement and maintenance of an IV catheter;
- Ability to swallow capsules;
Show all 16Show fewer
- Ability to communicate well with the investigators and to comply with study requirements;
- If female with reproductive potential, must be using a reliable method of birth control or abstaining from vaginal sexual intercourse;
- Estimated IQ greater than or equal to 85 determined by the Wechsler Abbreviated Scale of Intelligence;
- Right-handed.
- 18 to 45 years of age;
- BP and HR at or below the following values while sitting after five min rest: SBP 140 mm Hg, DBP 90 mm Hg, HR 100 bpm;
- Ability to communicate well with the investigator and to comply with study requirements;
- If female with reproductive potential, must be using a reliable method of birth control or abstaining from vaginal sexual intercourse;
- Estimated IQ greater than or equal to 85 determined by the Wechsler Abbreviated Scale of Intelligence;
- Right-handed.
Who cannot join
- 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 or that might interfere with the absorption, distribution, metabolism, or excretion of study drugs. Clinically significant is defined as being likely to affect the safety of the subject during his/her participation in this trial, or preclude achievement of the protocol objectives.
- Current tolerance to any substance other than nicotine or caffeine;
- Positive serological tests for syphilis or HIV infection;
- Positive purified protein derivative (PPD) test in the absence of a negative chest X-ray;
- History of a clinically significant adverse event associated with cannabis intoxication or withdrawal;
- History of epileptic seizures or head trauma with loss of consciousness greater than three min;
Show all 29Show fewer
- History of psychosis or any current DSM-IV axis I disorder (other than caffeine or nicotine dependence, or simple phobia);
- Family history of psychosis (except that related to acute drug intoxication) in a first-degree relative;
- Donation of more than 500 mL of blood within 30 days of study drug administration;
- Regular use of alcohol (greater than or equal to five standard drinks per day) four or more times per week in the month prior to study entry;
- If female, pregnant or nursing;
- ADHD Screening Rating Scale score greater than or equal to 24 on either the A or B subscale;
- Allergy to sesame seed oil (ingredient in dronabinol capsules), propylene glycol, ethanol, or peppermint oil (ingredients in Sativex(Registered Trademark));
- Currently interested in or participating in drug abuse treatment, or participated in drug abuse treatment within 60 days preceding study enrollment.
- Claustrophobia that precludes being able to tolerate an fMRI session.
- Magnetizable metal on or within the body that cannot be removed.
- Eligibility Criteria for Controls
- The goal of the eligibility criteria for control subjects is to obtain a group approximately comparable to the cannabis users in terms of age, sex, ethnicity, tobacco use, and intelligence.
- 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. Clinically significant is defined as being likely to affect the safety of the subject during his/her participation in this trial, or preclude achievement of the protocol objectives.
- A positive urine test for any illicit drug at any time during screening or study participation;
- Current physical dependence on any substance other than nicotine or caffeine; Self-reported lifetime use of any illicit drug other than cannabis; Self-reported lifetime use of cannabis greater than ten times, or use within the last year;
- Positive serological tests for syphilis or HIV infection;
- History of epileptic seizures or head trauma with loss of consciousness greater than three min;
- History of psychosis or any current DSM-IV axis I disorder (other than caffeine or nicotine dependence, or simple phobia);
- Regular use of alcohol (greater than or equal to five standard drinks per day) four or more times per week in the month prior to study entry;
- If female, pregnant or nursing;
- ADHD Screening Rating Scale score greater than or equal to 24 on either the A or B subscale;
- Claustrophobia that precludes being able to tolerate an fMRI session;
- Magnetizable metal on or within the body that cannot be removed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
About this study
Background:
- The therapeutic modalities of cannabis have received more research attention recently with the discovery of its ability to stimulate appetite and to provide pain and nausea relief in patients with AIDS, cancer, and multiple sclerosis, among other diseases. Sativex(Registered Trademark), an experimental drug derived from the marijuana plant, contains tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which affect brain activity. Sativex(Registered Trademark) is being tested to determine how and to what extent it affects brain activity.
- Functional magnetic resonance imaging (fMRI) uses magnetic waves to study brain activity. Researchers are interested in using fMRI to study how Sativex(Registered Trademark) affects regional brain activity, including thinking abilities and behavior.
Read more
Objectives:
- To study changes in regional brain activity produced by Sativex(Registered Trademark) compared with THC and placebo.
- To determine how Sativex(Registered Trademark) is processed by the body.
Eligibility:
- Individuals between 18 and 45 years of age who are either current users of cannabis (less than daily) or healthy volunteers who do not use cannabis.
Design:
- The study will involve one training session and five testing sessions on separate days.
- At every session, subjects will receive either THC or placebo capsules and either Sativex(Registered Trademark) or placebo spray.
- Participants will complete a training session in a mock fMRI scanner to adapt to the fMRI scanning environment. In the training session, participants will practice the tests that will track thinking ability, attention, working memory, and other cognitive tasks.
- Participants will have five fMRI scanning sessions with the tests they have practiced previously, and will provide blood, urine, and saliva samples as required by the researchers. Participants will be discharged approximately 12 hours after they arrive for the study sessions....
Read the detailed description
Background: Cannabis sativa contains over sixty cannabinoids, including delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). CBD lacks psychoactivity and may attenuate the subjective effects produced by THC. The ratio of THC:CBD in illicit cannabis in the US is approximately 20:1. Sativex(Registered Trademark), a whole-plant cannabinoid extract oromucosal spray, contains THC and CBD in a ratio of nearly 1:1. It was approved by Health Canada in 2005 as a prescription medication for neuropathic pain in multiple sclerosis (MS) and will be evaluated in Phase III trials in the U.S. in patients with advanced cancer for the treatment of pain refractory to opiates. No studies have examined changes in regional brain activity with functional magnetic resonance imaging (fMRI) during completion of cognitive tasks or affective measures after administration of Sativex(Registered Trademark).
Objective: 1) To characterize physiological and affective condition, subjective state, cognitive performance, and concomitant changes in activation of specific brain regions (blood oxygen level-dependent [BOLD] signal) with fMRI after oromucosal administration of Sativex(Registered Trademark) and oral administration of THC. 2) To characterize the pharmacokinetics of THC and CBD and metabolites in plasma, urine, and oral fluid.
Subject Population: 18 healthy controls and 18 healthy cannabis users, 18 - 45 years old, with no current major psychiatric disorders except nicotine or caffeine dependence. Non-dependent substance use is allowed for cannabis users. Cannabis using participants must have used cannabis with an average frequency of at least once in the last 90 days and maximum frequency of less than daily during the three months prior to study entry. Enrollment target, based on national population of adult current cannabis users and the Baltimore City Department of Planning 2000 census, is 65% male, 35% female; 64% African American, 32% Caucasian, 4% other; and 9% Hispanic and 91% non-Hispanic.
Experimental Design and Methods: This randomized, double blind, double-dummy, placebo-controlled, within- and between-subject study evaluates the effects of oral THC and oromucosal administration of Sativex(Registered Trademark) on brain activation and subjective, affective, cognitive, and physiologic measures. Cannabis users undergo a thorough medical, psychiatric (including structured diagnostic interview), and psychosocial (including Addiction Severity Index) evaluation. They enter the research unit the morning of the dosing/scanning session. Each cannabis-using participant receives, in random order, synthetic THC 5 mg, synthetic THC 15 mg, two actuations of Sativex(Registered Trademark) (5.4 mg THC and 5.0 mg cannabidiol), six actuations of Sativex(Registered Trademark) (16.2 mg THC and 15.0 mg cannabidiol), and placebo. There is an interval of at least five days between dosing sessions. Physiological, psychological, and behavioral measures are monitored throughout the study to determine onset, magnitude, and duration of effects and to correlate with THC and cannabidiol pharmacokinetics. Changes in BOLD signal in multiple brain areas are determined with five fMRI scans during the completion of cognitive tasks and affective measures after cannabinoid and placebo administration. Eighteen controls undergo neuroimaging, psychological, and behavioral monitoring as do cannabis users to control for practice effects. Primary outcome measures include changes in physiologic effects, subjective effects, BOLD signal, affect, and cognitive task performance in relation to THC, CBD, and metabolites plasma concentrations. Secondary objectives are to monitor the disposition of THC, CBD, and metabolites in plasma, urine, and oral fluid. Primary statistical analysis for changes in affect, cognitive performance, and physiologic and subjective effects is a within-subject analysis of variance (ANOVA) (or equivalent analysis). Changes in BOLD signal determined by fMRI are compared between groups and dosing conditions using repeated-measures ANOVA. Based upon power analyses, we estimate needing 18 cannabis users and 18 controls to complete the experiment.
Risks and Benefits: Potential risks are those associated with administration of cannabinoids, but proposed doses have proven safe and well tolerated in other studies. The most common side effects from the oromucosal administration of Sativex(Registered Trademark) include dry mouth, dizziness, application site discomfort, fatigue, somnolence, nausea, and diarrhea. Side effects resulting from oral THC administration include sedation, cognitive impairment, euphoria, poor coordination, tachycardia and hypotension. There are no clinical benefits to participants. Likely scientific benefits are greater understanding of the role of cannabidiol in modifying the impact of THC on cognitive performance, affective condition, subjective state, physiological condition, and brain activation.
- Conditions
- Cannabis, Dependence, Cannabis Abuse, Pharmacokinetics, fMRI
- Being tested
- Sativex(Registered Trademark), THC
- Keywords
- Sativex, fMRI, Alternative Matrices, Brain Imaging, THC
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sativex(Registered Trademark)Drug
THCDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics/Pharmacodynamics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study start8 May 2007
- Primary completion15 Aug 2011
- Study completion12 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CannabisStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037608
- Sponsor's protocol ID
- 999907423
- Other IDs
- 07-DA-N423
- Status last verified
- 12 Dec 2011
- First submitted
- 19 Dec 2009
- Last updated
- 2 Jul 2017
- 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, Gorelick DA, Heishman SJ, Preston KL, Nelson RA, Moolchan ET, Frank RA. Blockade of effects of smoked marijuana by the CB1-selective cannabinoid receptor antagonist SR141716. Arch Gen Psychiatry. 2001 Apr;58(4):322-8. doi: 10.1001/archpsyc.58.4.322.
PubMed 11296091Voth EA, Schwartz RH. Medicinal applications of delta-9-tetrahydrocannabinol and marijuana. Ann Intern Med. 1997 May 15;126(10):791-8. doi: 10.7326/0003-4819-126-10-199705150-00008.
PubMed 9148653
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sativex(Registered Trademark) and Oral THC on Attention, Affect, Working Memory, Reversal Learning, Physiology and Brain Activation
- ClinicalTrials.gov ID
- NCT01037608
- Acronym / sponsor ID
- 999907423
- Conditions
- Cannabis, Dependence, Cannabis Abuse, Pharmacokinetics, fMRI
- Keywords
- Sativex, fMRI, Alternative Matrices, Brain Imaging, THC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 8 May 2007
- Primary completion
- 15 Aug 2011 (actual)
- Study completion
- 12 Dec 2011 (actual)
- First posted
- 23 Dec 2009 (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:
- The therapeutic modalities of cannabis have received more research attention recently with the discovery of its ability to stimulate appetite and to provide pain and nausea relief in patients with AIDS, cancer, and multiple sclerosis, among other diseases. Sativex(Registered Trademark), an experimental drug derived from the marijuana plant, contains tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which affect brain activity. Sativex(Registered Trademark) is being tested to determine how and to what extent it affects brain activity.
- Functional magnetic resonance imaging (fMRI) uses magnetic waves to study brain activity. Researchers are interested in using fMRI to study how Sativex(Registered Trademark) affects regional brain activity, including thinking abilities and behavior.
Objectives:
- To study changes in regional brain activity produced by Sativex(Registered Trademark) compared with THC and placebo.
- To determine how Sativex(Registered Trademark) is processed by the body.
Eligibility:
- Individuals between 18 and 45 years of age who are either current users of cannabis (less than daily) or healthy volunteers who do not use cannabis.
Design:
- The study will involve one training session and five testing sessions on separate days.
- At every session, subjects will receive either THC or placebo capsules and either Sativex(Registered Trademark) or placebo spray.
- Participants will complete a training session in a mock fMRI scanner to adapt to the fMRI scanning environment. In the training session, participants will practice the tests that will track thinking ability, attention, working memory, and other cognitive tasks.
- Participants will have five fMRI scanning sessions with the tests they have practiced previously, and will provide blood, urine, and saliva samples as required by the researchers. Participants will be discharged approximately 12 hours after they arrive for the study sessions....
Detailed description
Background: Cannabis sativa contains over sixty cannabinoids, including delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). CBD lacks psychoactivity and may attenuate the subjective effects produced by THC. The ratio of THC:CBD in illicit cannabis in the US is approximately 20:1. Sativex(Registered Trademark), a whole-plant cannabinoid extract oromucosal spray, contains THC and CBD in a ratio of nearly 1:1. It was approved by Health Canada in 2005 as a prescription medication for neuropathic pain in multiple sclerosis (MS) and will be evaluated in Phase III trials in the U.S. in patients with advanced cancer for the treatment of pain refractory to opiates. No studies have examined changes in regional brain activity with functional magnetic resonance imaging (fMRI) during completion of cognitive tasks or affective measures after administration of Sativex(Registered Trademark).
Objective: 1) To characterize physiological and affective condition, subjective state, cognitive performance, and concomitant changes in activation of specific brain regions (blood oxygen level-dependent [BOLD] signal) with fMRI after oromucosal administration of Sativex(Registered Trademark) and oral administration of THC. 2) To characterize the pharmacokinetics of THC and CBD and metabolites in plasma, urine, and oral fluid.
Subject Population: 18 healthy controls and 18 healthy cannabis users, 18 - 45 years old, with no current major psychiatric disorders except nicotine or caffeine dependence. Non-dependent substance use is allowed for cannabis users. Cannabis using participants must have used cannabis with an average frequency of at least once in the last 90 days and maximum frequency of less than daily during the three months prior to study entry. Enrollment target, based on national population of adult current cannabis users and the Baltimore City Department of Planning 2000 census, is 65% male, 35% female; 64% African American, 32% Caucasian, 4% other; and 9% Hispanic and 91% non-Hispanic.
Experimental Design and Methods: This randomized, double blind, double-dummy, placebo-controlled, within- and between-subject study evaluates the effects of oral THC and oromucosal administration of Sativex(Registered Trademark) on brain activation and subjective, affective, cognitive, and physiologic measures. Cannabis users undergo a thorough medical, psychiatric (including structured diagnostic interview), and psychosocial (including Addiction Severity Index) evaluation. They enter the research unit the morning of the dosing/scanning session. Each cannabis-using participant receives, in random order, synthetic THC 5 mg, synthetic THC 15 mg, two actuations of Sativex(Registered Trademark) (5.4 mg THC and 5.0 mg cannabidiol), six actuations of Sativex(Registered Trademark) (16.2 mg THC and 15.0 mg cannabidiol), and placebo. There is an interval of at least five days between dosing sessions. Physiological, psychological, and behavioral measures are monitored throughout the study to determine onset, magnitude, and duration of effects and to correlate with THC and cannabidiol pharmacokinetics. Changes in BOLD signal in multiple brain areas are determined with five fMRI scans during the completion of cognitive tasks and affective measures after cannabinoid and placebo administration. Eighteen controls undergo neuroimaging, psychological, and behavioral monitoring as do cannabis users to control for practice effects. Primary outcome measures include changes in physiologic effects, subjective effects, BOLD signal, affect, and cognitive task performance in relation to THC, CBD, and metabolites plasma concentrations. Secondary objectives are to monitor the disposition of THC, CBD, and metabolites in plasma, urine, and oral fluid. Primary statistical analysis for changes in affect, cognitive performance, and physiologic and subjective effects is a within-subject analysis of variance (ANOVA) (or equivalent analysis). Changes in BOLD signal determined by fMRI are compared between groups and dosing conditions using repeated-measures ANOVA. Based upon power analyses, we estimate needing 18 cannabis users and 18 controls to complete the experiment.
Risks and Benefits: Potential risks are those associated with administration of cannabinoids, but proposed doses have proven safe and well tolerated in other studies. The most common side effects from the oromucosal administration of Sativex(Registered Trademark) include dry mouth, dizziness, application site discomfort, fatigue, somnolence, nausea, and diarrhea. Side effects resulting from oral THC administration include sedation, cognitive impairment, euphoria, poor coordination, tachycardia and hypotension. There are no clinical benefits to participants. Likely scientific benefits are greater understanding of the role of cannabidiol in modifying the impact of THC on cognitive performance, affective condition, subjective state, physiological condition, and brain activation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 18 to 45 years of age;
- Cannabis use with a minimum frequency of once in the last 90 days and maximum frequency of less than daily during the three months prior to study entry;
- 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;
- 12-lead standard ECG and three-minute rhythm strip without clinically relevant abnormalities;
- Peripheral veins suitable for repeated venipuncture and placement and maintenance of an IV catheter;
Key exclusion criteria (29 listed)
- 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 or that might interfere with the absorption, distribution, metabolism, or excretion of study drugs. Clinically significant is defined as being likely to affect the safety of the subject during his/her participation in this trial, or preclude achievement of the protocol objectives.
- Current tolerance to any substance other than nicotine or caffeine;
- Positive serological tests for syphilis or HIV infection;
- Positive purified protein derivative (PPD) test in the absence of a negative chest X-ray;
- History of a clinically significant adverse event associated with cannabis intoxication or withdrawal;
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 |
|---|---|---|
| Sativex(Registered Trademark) | Drug | – |
| THC | Drug | – |
Primary outcome
Pharmacokinetics/Pharmacodynamics
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 2 Jul 2017.
- 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 11296091Huestis MA, Gorelick DA, Heishman SJ, Preston KL, Nelson RA, Moolchan ET, Frank RA. Blockade of effects of smoked marijuana by the CB1-selective cannabinoid receptor antagonist SR141716. Arch Gen Psychiatry. 2001 Apr;58(4):322-8. doi: 10.1001/archpsyc.58.4.322.
- Background: PubMed 9148653Voth EA, Schwartz RH. Medicinal applications of delta-9-tetrahydrocannabinol and marijuana. Ann Intern Med. 1997 May 15;126(10):791-8. doi: 10.7326/0003-4819-126-10-199705150-00008.
Related trials for Cannabis
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sativex(Registered Trademark) and THC in people with Cannabis and Dependence, 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 16 inclusion and 29 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 2 Jul 2017. 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.
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?
Pharmacokinetics/Pharmacodynamics. 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 NCT01037608, which also lists 3 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 2 Jul 2017.