HealthyEarly Phase 1NCT01591629
The Effects of ∆-9-THC and Naloxone in Humans
A Early Phase 1 study testing Naloxone and Delta-9-THC in people with Healthy, run by Yale University at 1 site in United States.
Trial summary
The purpose of this project is to examine the effects of mu-opiate antagonism on the rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Naloxone and Delta-9-THC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2011to 1 Jun 2012
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least one exposure to Cannabis
Who cannot join
- Cannabis Naive
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Assessment of Cannabinoid-opiate Interactions in Humans With a Cannabis Use Disorder and Healthy Subjects
The purpose of this project is to examine the effects of mu-opiate antagonism on the rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis.
- Conditions
- Healthy
- Being tested
- Naloxone, Delta-9-THC, Placebo
- Keywords
- Cannabis, Marijuana, Naloxone, THC, Psychotic Disorders
- 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.
NaloxoneDrug
Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push
Delta-9-THCDrug
Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo and Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Active Naloxone and Placebo | Experimental | Not described Receives: Drug: Naloxone; Drug: Placebo |
| Placebo and Active Delta-9-THC | Placebo comparator | Not described Receives: Drug: Delta-9-THC; Drug: Placebo |
| Active Naloxone and Active Delta-9-THC | Experimental | Not described Receives: Drug: Naloxone; Drug: Delta-9-THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Measures
Subjective effects and perceptual alterations will be assessed using the Positive and Negative Symptom Subscale (PANNS).
Measured: 4 test days
Secondary outcomes (7)
Visual analog scales
Will assess subjective effects, perceptual alterations, and cognitive effects.
Measured: 4 test days
Clinician Administered Dissociative States Scales (CADSS)
Will measure subjective effects, perceptual alterations, and cognitive effects.
Measured: 4 test days
Psychotomimetic States Inventory (PSI)
Will assess subjective effects, perceptual alterations, and cognitive effects.
Measured: 4 test days
Marijuana Withdrawal Scale
Will assess subjective effects, perceptual alterations, and cognitive effects.
Measured: 4 test days
Clinical Opiate Withdrawal Scale
Will assess subjective effects, perceptual alterations, and cognitive effects.
Measured: 4 test days
Marijuana Craving Scale
Will assess subjective effects, perceptual alterations, and cognitive effects.
Measured: 4 test days
Neuro cognitive battery
Will assess cognitive effects.
Measured: 4 test days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study start4 Nov 2011
- Primary completion1 Jun 2012
- Study completion1 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepak C. D'Souza, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591629
- Sponsor's protocol ID
- 1108008940
- Status last verified
- Feb 2022
- First submitted
- 25 Apr 2012
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cannabinoid-opiate Interactions in Humans With a Cannabis Use Disorder and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01591629
- Acronym / sponsor ID
- 1108008940
- Conditions
- Healthy
- Keywords
- Cannabis, Marijuana, Naloxone, THC, Psychotic Disorders
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 4 Nov 2011 (actual)
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 4 May 2012 (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 project is to examine the effects of mu-opiate antagonism on the rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo and Placebo | Placebo comparator | Drug: Placebo |
| Active Naloxone and Placebo | Experimental | Drug: Naloxone, Drug: Placebo |
| Placebo and Active Delta-9-THC | Placebo comparator | Drug: Delta-9-THC, Drug: Placebo |
| Active Naloxone and Active Delta-9-THC | Experimental | Drug: Naloxone, Drug: Delta-9-THC |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- At least one exposure to Cannabis
Key exclusion criteria (1 listed)
- Cannabis Naive
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 |
|---|---|---|
| NaloxoneActive Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push | Drug | Active Naloxone and Active Delta-9-THC, Active Naloxone and Placebo |
| Delta-9-THCActive Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes. | Drug | Active Naloxone and Active Delta-9-THC, Placebo and Active Delta-9-THC |
| PlaceboPlacebo | Drug | Active Naloxone and Placebo, Placebo and Active Delta-9-THC, Placebo and Placebo |
Primary outcome
Behavioral Measures
Time frame: 4 test days
Subjective effects and perceptual alterations will be assessed using the Positive and Negative Symptom Subscale (PANNS).
7 secondary outcomes
Visual analog scales
Time frame: 4 test days
Clinician Administered Dissociative States Scales (CADSS)
Time frame: 4 test days
Psychotomimetic States Inventory (PSI)
Time frame: 4 test days
Marijuana Withdrawal Scale
Time frame: 4 test days
Clinical Opiate Withdrawal Scale
Time frame: 4 test days
Marijuana Craving Scale
Time frame: 4 test days
Neuro cognitive battery
Time frame: 4 test days
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 9 Mar 2022.
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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 Naloxone and Delta-9-THC in people with Healthy, 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 1 inclusion and 1 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Behavioral Measures (time frame: 4 test days). 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 9 Mar 2022.