CannabisPhase 1/2NCT03251326
Nabilone in Cannabis Users With PTSD
A Phase 1/2 study testing Nabilone, Cannabis and Propranolol in people with Cannabis and Post Traumatic Stress Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Despite the prevalence of cannabis use among the PTSD population and self-reports that it is used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are unknown. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Cannabis, Post Traumatic Stress Disorder
- What is being tested?
- Nabilone, Cannabis and Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jun 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current cannabis use
- PTSD symptoms
- Able to give informed consent and comply with study procedures
- Women who are normally cycling and practicing an effective form of birth control other than hormonal contraceptives
Who cannot join
- Meeting criteria for certain current psychiatric disorders
- Clinical laboratory tests outside of normal limits
- History of clinically significant cardiac or respiratory diagnoses
- Current parole or probation
- Women who are currently pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD
Despite the prevalence of cannabis use among the PTSD population and self-reports that it is used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are unknown. The purpose of this placebo-controlled, within-subject study is to assess the effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in cannabis smokers with PTSD.
Read the detailed description
This study will compare the effects of smoked cannabis and nabilone on attentional bias toward trauma- related stimuli, subjective and emotional processing to a range of trauma-and non-trauma-related images and physiological reactivity to these stimuli in individuals with CUD and PTSD. Importantly, this study will also probe the abuse related potential of nabilone compared to smoked cannabis in this population, a critical aspect in determining the potential feasibility for its use clinically to treat CUD in PTSD populations. The effects of nabilone will be compared to propranolol as a positive control.
- Conditions
- Cannabis, Post Traumatic Stress Disorder
- Being tested
- Nabilone, Cannabis, Propranolol, Placebo
- Medical subject headings
- Marijuana Abuse, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NabiloneDrug
Nabilone capsules (4 mg)
CannabisDrug
Cigarettes (0.0 and 5.6% THC)
PropranololDrug
Propranolol capsules (40mg)
PlaceboDrug
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Nabilone | Experimental | Nabilone capsules (4 mg) Receives: Drug: Nabilone |
| Propranolol | Active comparator | Propranolol capsules (40mg) Receives: Drug: Propranolol |
| Smoked cannabis | Experimental | (0.0 and 5.6% THC) Receives: Drug: Cannabis |
| Placebo | Placebo comparator | Placebo capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cue Reactivity (Emotional Stroop Task)
We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study startOct 2015
- Primary completionJun 2019
- Study completionJun 2019
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Margaret Haney, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251326
- Sponsor's protocol ID
- 6971
- Other IDs
- U54DA037842
- Status last verified
- Jun 2022
- First submitted
- 14 Aug 2017
- Last updated
- 15 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD
- ClinicalTrials.gov ID
- NCT03251326
- Acronym / sponsor ID
- 6971
- Conditions
- Cannabis, Post Traumatic Stress Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Posted 12 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the prevalence of cannabis use among the PTSD population and self-reports that it is used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are unknown. The purpose of this placebo-controlled, within-subject study is to assess the effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in cannabis smokers with PTSD.
Detailed description
This study will compare the effects of smoked cannabis and nabilone on attentional bias toward trauma- related stimuli, subjective and emotional processing to a range of trauma-and non-trauma-related images and physiological reactivity to these stimuli in individuals with CUD and PTSD. Importantly, this study will also probe the abuse related potential of nabilone compared to smoked cannabis in this population, a critical aspect in determining the potential feasibility for its use clinically to treat CUD in PTSD populations. The effects of nabilone will be compared to propranolol as a positive control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).
| Arm | Type | Receives |
|---|---|---|
| Nabilone | Experimental | Drug: NabiloneNabilone capsules (4 mg) |
| Propranolol | Active comparator | Drug: PropranololPropranolol capsules (40mg) |
| Smoked cannabis | Experimental | Drug: Cannabis(0.0 and 5.6% THC) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Current cannabis use
- PTSD symptoms
- Able to give informed consent and comply with study procedures
- Women who are normally cycling and practicing an effective form of birth control other than hormonal contraceptives
Key exclusion criteria (5 listed)
- Meeting criteria for certain current psychiatric disorders
- Clinical laboratory tests outside of normal limits
- History of clinically significant cardiac or respiratory diagnoses
- Current parole or probation
- Women who are currently pregnant or breastfeeding
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 |
|---|---|---|
| NabiloneNabilone capsules (4 mg) | Drug | Nabilone |
| CannabisCigarettes (0.0 and 5.6% THC) | Drug | Smoked cannabis |
| PropranololPropranolol capsules (40mg) | Drug | Propranolol |
| PlaceboPlacebo capsules | Drug | Placebo |
Primary outcome
Cue Reactivity (Emotional Stroop Task)
Time frame: 1 month
We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cannabis
RecruitingPhase 3
Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder
Cannabis Withdrawal
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
Recruiting
MATAspire: Mental Health Awareness Tailored App for Substance Prevention and Integrated Resilience Education
Alcohol Use, Cannabis Use
RecruitingObservational study
A Study in Patients Reporting Cannabis Use Followed With an Application-Based Cannabis Journal
Cancer
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
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 1/2 study testing Nabilone, Cannabis and Propranolol in people with Cannabis and Post Traumatic Stress Disorder, run by New York State Psychiatric Institute 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 4 inclusion and 5 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 15 Jul 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cue Reactivity (Emotional Stroop Task) (time frame: 1 month). 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 15 Jul 2022.