CannabisEarly Phase 1NCT01853020
Cannabinoids and Cerebellar-Motor Functioning
A Early Phase 1 study testing THC in people with Cannabis and Psychotic Disorders, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis, Psychotic Disorders
- What is being tested?
- THC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to 7 Apr 2015
- Phase
- Early 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have used cannabis at least once in their lifetime
- No cannabis use in the past month
- Men and women aged 21 to 35 years (extremes included) on the day of the first dosing
Who cannot join
- Hearing deficits
- Psychiatric or mental disorders
- Hearing Deficits
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.
Read the detailed description
The overall aim of the current proposal is to investigate whether acute, IV ∆9-THC administration mediates cerebellar versus forebrain-dependent associative learning in humans as assessed with eyeblink conditioning (EBC). In addition, a battery of motor function tests will also be administered (the CANTAB motor screening test, Grooved Pegboard Motor Task, paced finger tapping).
- Conditions
- Cannabis, Psychotic Disorders
- Being tested
- THC, Placebo
- Keywords
- Cannabinoids, Eyeblink Conditioning, EBC
- Medical subject headings
- Marijuana Abuse, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THCDrug
Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
Low Dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
PlaceboDrug
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| THC | Active comparator | Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes. Receives: Drug: THC |
| Placebo | Placebo comparator | Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebellum Dependent Associative Learning (% CRs)
% conditioned responses (CRs) will be measured
Measured: Measured +15 minutes after infusion
Cerebellum Dependent Associative Learning (CR Latency)
conditioned response (CR) Latency will be measured
Measured: Measured +15 minutes after infusion
Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy)
Total time taken to complete the grooved pegboard tasks will be the dependent measure.
Measured: Measured +45 minutes after infusion
CANTAB Motor Screening Test (Reaction Time)
Using a touch screen, reaction time to touch a target will be the dependent measures.
Measured: Measured +45 minutes after infusion
CANTAB Motor Screening Test (Accuracy)
Using a touch screen, accuracy to touch a target will be the dependent measures.
Measured: Measured +45 minutes after infusion
Paced Finger Tapping (Correct Responses)
Using a button on a computer keyboard, correct responses will be measured.
Measured: Measured +45 minutes after infusion
Paced Finger Tapping (Reaction Time)
Using a button on a computer keyboard, reaction time and tapping variability will be measured.
Measured: Measured +45 minutes after infusion
Secondary outcomes (1)
THC intoxication, as measured by the Visual Analog Scale (Total Score)
0 being none; 100 being completely
Measured: Baseline; +45, +100, +240 minutes after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startDec 2012
- Primary completion7 Apr 2015
- Study completion7 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853020
- Sponsor's protocol ID
- 1211011055
- Status last verified
- Sep 2024
- First submitted
- 25 Mar 2013
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabinoids and Cerebellar-Motor Functioning
- ClinicalTrials.gov ID
- NCT01853020
- Acronym / sponsor ID
- 1211011055
- Conditions
- Cannabis, Psychotic Disorders
- Keywords
- Cannabinoids, Eyeblink Conditioning, EBC
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- 7 Apr 2015 (actual)
- Study completion
- 7 Apr 2015 (actual)
- First posted
- 14 May 2013 (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 this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.
Detailed description
The overall aim of the current proposal is to investigate whether acute, IV ∆9-THC administration mediates cerebellar versus forebrain-dependent associative learning in humans as assessed with eyeblink conditioning (EBC). In addition, a battery of motor function tests will also be administered (the CANTAB motor screening test, Grooved Pegboard Motor Task, paced finger tapping).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THC | Active comparator | Drug: THCVery low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes. Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes. Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes. |
| Placebo | Placebo comparator | Drug: PlaceboControl: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must have used cannabis at least once in their lifetime
- No cannabis use in the past month
- Men and women aged 21 to 35 years (extremes included) on the day of the first dosing
Key exclusion criteria (3 listed)
- Hearing deficits
- Psychiatric or mental disorders
- Hearing Deficits
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 |
|---|---|---|
| THCVery low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes. Low Dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes. Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes. | Drug | THC |
| PlaceboControl: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes. | Drug | Placebo |
Primary outcome
Cerebellum Dependent Associative Learning (% CRs)
Time frame: Measured +15 minutes after infusion
% conditioned responses (CRs) will be measured
Cerebellum Dependent Associative Learning (CR Latency)
Time frame: Measured +15 minutes after infusion
conditioned response (CR) Latency will be measured
Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy)
Time frame: Measured +45 minutes after infusion
Total time taken to complete the grooved pegboard tasks will be the dependent measure.
CANTAB Motor Screening Test (Reaction Time)
Time frame: Measured +45 minutes after infusion
Using a touch screen, reaction time to touch a target will be the dependent measures.
CANTAB Motor Screening Test (Accuracy)
Time frame: Measured +45 minutes after infusion
Using a touch screen, accuracy to touch a target will be the dependent measures.
Paced Finger Tapping (Correct Responses)
Time frame: Measured +45 minutes after infusion
Using a button on a computer keyboard, correct responses will be measured.
Paced Finger Tapping (Reaction Time)
Time frame: Measured +45 minutes after infusion
Using a button on a computer keyboard, reaction time and tapping variability will be measured.
1 secondary outcome
THC intoxication, as measured by the Visual Analog Scale (Total Score)
Time frame: Baseline; +45, +100, +240 minutes after infusion
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 19 Sep 2024.
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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.
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 Early Phase 1 study testing THC in people with Cannabis and Psychotic Disorders, run by Yale 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 3 inclusion and 3 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 19 Sep 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Cerebellum Dependent Associative Learning (% CRs) (time frame: Measured +15 minutes after infusion). The study lists 7 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 19 Sep 2024.