HealthyEarly Phase 1NCT02335060
N-acetylcysteine Effects on Tetrahydrocannabinol
A Early Phase 1 study testing Delta-9-THC and N-acetylcysteine in people with Healthy, run by Yale University at 1 site in United States.
Trial summary
The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with NAC and then assessing their responses to THC. 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?
- Delta-9-THC and N-acetylcysteine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2014to 16 Sep 2014
- 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
- Exposed to Cannabis at least once in lifetime
Who cannot join
- Cannabis Naive
- Individuals with a documented allergy to N-acetylcysteine
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: Effect of N-acetylcysteine on the Acute Cognitive Effects of Delta-9-Tetrahydrocannabinol
The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with NAC and then assessing their responses to THC.
- Conditions
- Healthy
- Being tested
- Delta-9-THC, N-acetylcysteine, Placebo
- Keywords
- cannabis, Marijuana, THC, N-acetylcysteine, 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.
Delta-9-THCDrug
Active Delta-9-THC (0.036mg/Kg) given intravenously.
N-acetylcysteineDrug
A pill given orally.
PlaceboDrug
Placebo (about a quarter spoon of alcohol with no THC) given intravenously.
PlaceboDrug
Placebo "sugar" pill given orally with no N-acetylcysteine.
| Study group | Role | What they receive |
|---|---|---|
| Active N-acetylcysteine and Active Delta-9-THC | Experimental | Not described Receives: Drug: Delta-9-THC; Drug: N-acetylcysteine |
| Placebo and Active Delta-9-THC | Placebo comparator | Not described Receives: Drug: Delta-9-THC; Drug: Placebo |
| Active N-acetylcysteine and Placebo | Experimental | Not described Receives: Drug: N-acetylcysteine; Drug: Placebo |
| Placebo and Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Measured: -30 minutes from administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Measured: +15 minutes from administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Measured: +90 minutes from administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Measured: +240 minutes from administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Measured: -60 minutes from administration of THC
Secondary outcomes (5)
Clinician Administered Dissociative Symptoms Scale (CADSS)
Perceptual alterations will be measured using the CADSS. This is a scale consisting of 19 self-reported items and 8 clinician-rated items. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.
Measured: -60min, -30min, +15min, +90min, +240min from administration of THC
Visual Analog Scale (VAS)
Feeling states associated with cannabis intoxication will be measured using a self-reported visual analog scale of feeling states associated with cannabis effects (ex: "high," "calm," "anxious"). Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11mm line. These data will be captured to validate that the experiment is relevant to cannabis effects.
Measured: -60min, -30min, +15min, +90min, +240min from administration of THC
Cognitive Test Battery
Several computer tasks will be administered in order to evaluate the effects of cannabis on recognition memory, working memory, and attention. The battery consists of four computer tasks that lasts no longer than 20 minutes in total.
Measured: +20min from administration of THC
Hopkins Verbal Learning Test (HVLT)
The HVLT is a 12 word list that is semantically organized. The task consists of 5 trials and a different version of the HVLT will be administered on each test day.
Measured: +20min from administration of THC
Psychotomimetic States Inventory (PSI)
The PSI is a measure of drug induced psychotomimetic states. This self-reported scale consists of 28 items rated 0 (not at all) to 3 (extremely) and will facilitate the characterization of a wide range of dissociative/hallucinatory phenomena as well as cognitive disorganization associated with the administration of THC.
Measured: -60min, -30min, +240min from administration of THC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study start2 May 2014
- Primary completion16 Sep 2014
- Study completion16 Sep 2014
Why it stopped: Feasibility pilot was completed
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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohini Ranganathan, Yale University
- Investigators
- Mohini Ranganathan, MD, Principal investigator, Yale University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335060
- Sponsor's protocol ID
- 1402013406
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2015
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-acetylcysteine on the Acute Cognitive Effects of Delta-9-Tetrahydrocannabinol
- ClinicalTrials.gov ID
- NCT02335060
- Acronym / sponsor ID
- 1402013406
- Conditions
- Healthy
- Keywords
- cannabis, Marijuana, THC, N-acetylcysteine, Psychotic Disorders
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility pilot was completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 2 May 2014 (actual)
- Primary completion
- 16 Sep 2014 (actual)
- Study completion
- 16 Sep 2014 (actual)
- First posted
- 9 Jan 2015 (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 overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with NAC and then assessing their responses to THC.
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 |
|---|---|---|
| Active N-acetylcysteine and Active Delta-9-THC | Experimental | Drug: Delta-9-THC, Drug: N-acetylcysteine |
| Placebo and Active Delta-9-THC | Placebo comparator | Drug: Delta-9-THC, Drug: Placebo |
| Active N-acetylcysteine and Placebo | Experimental | Drug: N-acetylcysteine, Drug: Placebo |
| Placebo and Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Exposed to Cannabis at least once in lifetime
Key exclusion criteria (2 listed)
- Cannabis Naive
- Individuals with a documented allergy to N-acetylcysteine
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 |
|---|---|---|
| Delta-9-THCActive Delta-9-THC (0.036mg/Kg) given intravenously. | Drug | Active N-acetylcysteine and Active Delta-9-THC, Placebo and Active Delta-9-THC |
| N-acetylcysteineA pill given orally. | Drug | Active N-acetylcysteine and Active Delta-9-THC, Active N-acetylcysteine and Placebo |
| PlaceboPlacebo (about a quarter spoon of alcohol with no THC) given intravenously. | Drug | Active N-acetylcysteine and Placebo, Placebo and Placebo |
| PlaceboPlacebo "sugar" pill given orally with no N-acetylcysteine. | Drug | Placebo and Active Delta-9-THC, Placebo and Placebo |
Primary outcome
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time frame: -30 minutes from administration of THC
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time frame: +15 minutes from administration of THC
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time frame: +90 minutes from administration of THC
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time frame: +240 minutes from administration of THC
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time frame: -60 minutes from administration of THC
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
5 secondary outcomes
Clinician Administered Dissociative Symptoms Scale (CADSS)
Time frame: -60min, -30min, +15min, +90min, +240min from administration of THC
Visual Analog Scale (VAS)
Time frame: -60min, -30min, +15min, +90min, +240min from administration of THC
Cognitive Test Battery
Time frame: +20min from administration of THC
Hopkins Verbal Learning Test (HVLT)
Time frame: +20min from administration of THC
Psychotomimetic States Inventory (PSI)
Time frame: -60min, -30min, +240min from administration of THC
Results and safety
The study was stopped early (reason given: Feasibility pilot was completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 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.
Mohini Ranganathan, MD principal investigator
Yale University Medical School
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 Delta-9-THC and N-acetylcysteine 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 2 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: stopped early, as of the sponsor's last update on 31 Jan 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 was stopped early (reason given: Feasibility pilot was completed). Results are not available in the source record.
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?
Positive and Negative Symptom Scale for Schizophrenia (PANSS) (time frame: -30 minutes from administration of THC). The study lists 5 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 31 Jan 2022.