RewardPhase 1FIXNCT00628706
Investigating the Acute Effects of THC on Functional Brain Systems
A Phase 1 study testing Delta9-tetrahydrocannabinol (THC) in people with Reward and Tetrahydrocannabinol, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Reward, Tetrahydrocannabinol, Endocannabinoids
- What is being tested?
- Delta9-tetrahydrocannabinol (THC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2008to Sep 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- History of mild cannabis use for at least one year (<1/week and ≥ 4/year)
- History without psychotic experiences after cannabis use
- Age between 18 and 45 years
- Right-handedness, assessed with the Edinburgh Handedness Inventory
- Written informed consent of the subject
Who cannot join
- Any clinical significant abnormality of any clinical laboratory test, including urinary drug screening
- Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests
- History of clinically significant psychiatric or neurological illness
- History of clinically significant psychiatric or neurological illness in first- or second-degree relatives
- History of alcohol and/or drug abuse (DSM-IV criteria)
- Body Mass Index (B.M.I.) <18 kg/m2 or >28 kg/m2
Show all 13Show fewer
- Paranoid ideation or psychoticism on SCL-90
- Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug
- The use of any medication within three weeks prior to the start of the study, except for paracetamol
- Positive HIV or Hepatitis B/C test
- Blood donation within 3 months before the start of the study
- Claustrophobia
- Metal objects in or around the body (braces, pacemaker, metal fragments)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.
Read the detailed description
Cannabis is by far the most frequently used illicit drug worldwide and has significant effects on memory. Further, cannabis has an addictive potential. These effects are mediated by an action of THC, the main psychoactive ingredient of cannabis, on cannabinoid CB1 receptors. These receptors are particularly highly expressed in brain regions involved in memory and reward. Therefore, in this study we will investigate the acute effects of THC on functional brain systems underlying memory and reward. We will visualize these effects using the latest non-invasive imaging technique: pharmacological MRI (phMRI).
- Being tested
- Delta9-tetrahydrocannabinol (THC)
- Keywords
- tetrahydrocannabinol, memory, reward, magnetic resonance imaging, endocannabinoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta9-tetrahydrocannabinol (THC)Drug
Also called dronabinol, marinol, THC, tetrahydrocannabinol
inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Inhalation of THC, using a Volcano vaporizer Receives: Drug: Delta9-tetrahydrocannabinol (THC) |
| B | Placebo comparator | Inhalation of vehicle, using a Volcano vaporizer Receives: Drug: Delta9-tetrahydrocannabinol (THC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main study parameter is the blood oxygen level dependent (BOLD) signal.
Measured: 4 months
Secondary outcomes (4)
Behavioral parameters (two VAS questionnaires)
Measured: 4 months
Cerebral blood flow (ASL)
Measured: 4 months
Concentration of plasma THC and its main metabolites
Measured: 4 months
Performance on neuropsychological tests
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RewardStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Human Drug Research, Leiden University Medical Center, TI Pharma
- Investigators
- Nick Ramsey, Professor, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628706
- Sponsor's protocol ID
- THC-phMRI-01
- Acronym
- FIX
- Status last verified
- Feb 2009
- First submitted
- 24 Feb 2008
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bossong MG, Jager G, van Hell HH, Zuurman L, Jansma JM, Mehta MA, van Gerven JM, Kahn RS, Ramsey NF. Effects of Delta9-tetrahydrocannabinol administration on human encoding and recall memory function: a pharmacological FMRI study. J Cogn Neurosci. 2012 Mar;24(3):588-99. doi: 10.1162/jocn_a_00156. Epub 2011 Nov 8.
PubMed 22066583
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Acute Effects of THC on Functional Brain Systems
- ClinicalTrials.gov ID
- NCT00628706
- Acronym / sponsor ID
- FIX / THC-phMRI-01
- Keywords
- tetrahydrocannabinol, memory, reward, magnetic resonance imaging, endocannabinoids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Center for Human Drug Research, Leiden University Medical Center, TI Pharma
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 Mar 2008 (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 determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.
Detailed description
Cannabis is by far the most frequently used illicit drug worldwide and has significant effects on memory. Further, cannabis has an addictive potential. These effects are mediated by an action of THC, the main psychoactive ingredient of cannabis, on cannabinoid CB1 receptors. These receptors are particularly highly expressed in brain regions involved in memory and reward. Therefore, in this study we will investigate the acute effects of THC on functional brain systems underlying memory and reward. We will visualize these effects using the latest non-invasive imaging technique: pharmacological MRI (phMRI).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Delta9-tetrahydrocannabinol (THC)Inhalation of THC, using a Volcano vaporizer |
| B | Placebo comparator | Drug: Delta9-tetrahydrocannabinol (THC)Inhalation of vehicle, using a Volcano vaporizer |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- History of mild cannabis use for at least one year (<1/week and ≥ 4/year)
- History without psychotic experiences after cannabis use
- Age between 18 and 45 years
- Right-handedness, assessed with the Edinburgh Handedness Inventory
- Written informed consent of the subject
Key exclusion criteria (13 listed)
- Any clinical significant abnormality of any clinical laboratory test, including urinary drug screening
- Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests
- History of clinically significant psychiatric or neurological illness
- History of clinically significant psychiatric or neurological illness in first- or second-degree relatives
- History of alcohol and/or drug abuse (DSM-IV criteria)
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 |
|---|---|---|
| Delta9-tetrahydrocannabinol (THC)Also: dronabinol, marinol, THC, tetrahydrocannabinolinhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer | Drug | A, B |
Primary outcome
The main study parameter is the blood oxygen level dependent (BOLD) signal.
Time frame: 4 months
4 secondary outcomes
Behavioral parameters (two VAS questionnaires)
Time frame: 4 months
Cerebral blood flow (ASL)
Time frame: 4 months
Concentration of plasma THC and its main metabolites
Time frame: 4 months
Performance on neuropsychological tests
Time frame: 4 months
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 18 Feb 2009.
- Derived from this study: PubMed 22066583Bossong MG, Jager G, van Hell HH, Zuurman L, Jansma JM, Mehta MA, van Gerven JM, Kahn RS, Ramsey NF. Effects of Delta9-tetrahydrocannabinol administration on human encoding and recall memory function: a pharmacological FMRI study. J Cogn Neurosci. 2012 Mar;24(3):588-99. doi: 10.1162/jocn_a_00156. Epub 2011 Nov 8.
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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.
Nick Ramsey, Professor principal investigator
UMC Utrecht
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 Delta9-tetrahydrocannabinol (THC) in people with Reward and Tetrahydrocannabinol, run by UMC Utrecht at 1 site in Netherlands.
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 5 inclusion and 13 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 18 Feb 2009. 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 Netherlands. 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?
The main study parameter is the blood oxygen level dependent (BOLD) signal. (time frame: 4 months). 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 NCT00628706, which also lists 1 linked publication.
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 18 Feb 2009.