Cannabis Use DisorderPhase 2FAAH-I MULTINCT03386487

Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)

A Phase 2 study testing PF 04457845 in people with Cannabis Use Disorder, run by Yale University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Phase 2B, 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 in Adults with DSM-5 Current Cannabis Use Disorder (CUD) Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Cannabis Use Disorder
What is being tested?: PF 04457845
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 228 participants
Where: 4 sitesUnited States
Study dates: 14 Jan 2019to 25 Jul 2022
Phase: Phase 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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Ages 18-60 years, inclusive.
Male or Female.
Individuals with DSM-V criteria for Cannabis Use Disorder .
Positive for urinary THC-COOH at both screening visits.
Must express a willingness at screening to set a date within the first week of randomization to attempt to quit using cannabis.

Who cannot join

Clinically significant unstable medical disorders (as determined by the site investigator).
Laboratory tests with clinically significant abnormalities (as determined by the site investigator)
Pregnancy by history and or laboratory confirmation (serum HCG).
Lactation.
Physiological dependence on another substance.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Johns Hopkins University
Baltimore, Maryland, 21224
Medical University of South Carolina
Charleston, South Carolina, 29425
Connecticut Mental Health Center
New Haven, Connecticut, 06519
Columbia University Medical College / New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

Official title: A Phase 2B, 8-week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 in Adults With DSM5 Current Cannabis Use Disorder (CUD)

Read the detailed description

The efficacy, safety and tolerability of the FAAH Inhibitor PF-0447845 in reducing cannabis use will be studied in a 4-site randomized, double-blind, placebo-controlled, parallel-group, outpatient clinical trial comparing PF-04457845 (4mg) and placebo in DSM-5 CUD individuals. Participants will be randomized in a 1:1 ratio to either PF-04457845 or placebo using random block sizes of 2 and 4, stratified by site and degree of cannabis use. Participants will receive motivational interviewing for 2 weeks before being randomized to receive study medication to make a quit attempt within the first week of treatment. Participants will receive active or placebo PF-04457845 for 8 weeks during which time they will be evaluated weekly in face to face visits. In addition, daily assessment of adherence to study medication and cannabinoid use will be conducted daily by cellphone. Measures of cannabinoid exposure (self-reported and urine toxicology), and problems related to the use of cannabis, will be assessed.

Conditions: Cannabis Use Disorder
Being tested: PF 04457845, Placebo Oral Tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF 04457845Drug
Study medication will be administered at 4mg by mouth daily for eight weeks.
Placebo Oral TabletDrug
Placebo comparator will be administered by mouth daily for eight weeks.

Study groups in NCT03386487
Study group	Role	What they receive
PF-04457845	Active comparator	Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks Receives: Drug: PF 04457845
Placebo	Placebo comparator	Subjects will be randomized to placebo Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Time Line Follow Back (TLFB) for Cannabis Use
Change in the average number of times per day of self-reported cannabis consumption measured by the Timeline Follow Back approach for Cannabis Use in which participants quantify and report their frequency of cannabis use prior to study participation and throughout the study. Differences between groups in the change from baseline use (2 weeks prior to randomization) in the average number of times per day of self-reported consumption of cannabis or a cannabis containing product in the last 4 weeks of treatment captured using the daily TLFB data collected during CAROMA calls.
Measured: Change from baseline in self reported cannabis use as measured by the TLFB approach at baseline and then weekly average daily use over 8 weeks.
Urinary Levels of THC-COOH (ng/ml)
Assay of the levels of the principal metabolite of THC (THC-COOH) in urine samples at baseline and bi-weekly over 8 weeks.
Measured: baseline, week 1, week 3, week 5, week 7, and week 9 visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 201925 Jul 2022

First posted29 Dec 2017
Study start14 Jan 2019
Primary completion25 Jul 2022
Study completion25 Jul 2022

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 Cannabis Use DisorderStudies 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: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Phase 2B
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03386487
Sponsor's protocol ID: 2000022450
Other IDs: 1U01DA045372-01
Acronym: FAAH-I MULTI
Status last verified: Feb 2024
First submitted: 21 Dec 2017
Last updated: 14 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cannabis Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2B, 8-week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 in Adults With DSM5 Current Cannabis Use Disorder (CUD)
ClinicalTrials.gov ID: NCT03386487
Acronym / sponsor ID: FAAH-I MULTI / 2000022450
Conditions: Cannabis Use Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Columbia University, Johns Hopkins University, Medical University of South Carolina, National Institute on Drug Abuse (NIDA)
Study start: 14 Jan 2019 (actual)
Primary completion: 25 Jul 2022 (actual)
Study completion: 25 Jul 2022 (actual)
First posted: 29 Dec 2017 (actual)
Results: Posted 14 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Phase 2B

Arm	Type	Receives
PF-04457845	Active comparator	Drug: PF 04457845Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
Placebo	Placebo comparator	Drug: Placebo Oral TabletSubjects will be randomized to placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Ages 18-60 years, inclusive.
Male or Female.
Individuals with DSM-V criteria for Cannabis Use Disorder .
Positive for urinary THC-COOH at both screening visits.
Must express a willingness at screening to set a date within the first week of randomization to attempt to quit using cannabis.

Key exclusion criteria (5 listed)

Clinically significant unstable medical disorders (as determined by the site investigator).
Laboratory tests with clinically significant abnormalities (as determined by the site investigator)
Pregnancy by history and or laboratory confirmation (serum HCG).
Lactation.
Physiological dependence on another substance.

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
PF 04457845Study medication will be administered at 4mg by mouth daily for eight weeks.	Drug	PF-04457845
Placebo Oral TabletPlacebo comparator will be administered by mouth daily for eight weeks.	Drug	Placebo

Primary outcome

Time Line Follow Back (TLFB) for Cannabis Use
Time frame: Change from baseline in self reported cannabis use as measured by the TLFB approach at baseline and then weekly average daily use over 8 weeks.
Change in the average number of times per day of self-reported cannabis consumption measured by the Timeline Follow Back approach for Cannabis Use in which participants quantify and report their frequency of cannabis use prior to study participation and throughout the study. Differences between groups in the change from baseline use (2 weeks prior to randomization) in the average number of times per day of self-reported consumption of cannabis or a cannabis containing product in the last 4 weeks of treatment captured using the daily TLFB data collected during CAROMA calls.
Urinary Levels of THC-COOH (ng/ml)
Time frame: baseline, week 1, week 3, week 5, week 7, and week 9 visits
Assay of the levels of the principal metabolite of THC (THC-COOH) in urine samples at baseline and bi-weekly over 8 weeks.

Results and safety

Results posted to the registry on 14 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-04457845	116	89
Placebo	112	91

Primary outcome: Time Line Follow Back (TLFB) for Cannabis Use

Time frame: Change from baseline in self reported cannabis use as measured by the TLFB approach at baseline and then weekly average daily use over 8 weeks.. Mean (Standard Deviation). Unit: times/day of self-reported cannabis use

Measure	PF-04457845 n = 105	Placebo n = 109
Week 1	1.921 (1.538)	1.768 (1.758)
Week 2	1.201 (1.638)	1.066 (1.702)
Week 3	1.308 (1.881)	1.06 (1.663)
Week 4	1.316 (1.956)	0.998 (1.414)
Week 5	1.234 (1.8)	1.214 (2.22)
Week 6	1.252 (1.639)	1.079 (1.645)
Week 7	1.321 (1.762)	0.91 (1.3)
Week 8	1.113 (1.481)	0.936 (1.417)

Primary outcome: Urinary Levels of THC-COOH (ng/ml)

Time frame: baseline, week 1, week 3, week 5, week 7, and week 9 visits. Mean (Standard Deviation). Unit: ng/ml

Measure	PF-04457845 n = 106	Placebo n = 106
Screening	5.959 (6.633)	5.571 (6.542)
Week 1	5.077 (4.837)	5.747 (7.456)
Week 3	3.069 (3.385)	3.92 (6.673)
Week 5	3.482 (5.064)	4.465 (7.411)
Week 7	3.241 (5.67)	4.223 (7.724)
Week 9	3.222 (3.913)	3.952 (7.511)

Adverse events

Time frame: The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-04457845	2 of 116 (1.7%)	89 of 116 (76.7%)	0 of 116
Placebo	0 of 112 (0%)	91 of 112 (81.3%)	0 of 112

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Deepak C D'Souza, MD principal investigator

Yale University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF 04457845 in people with Cannabis Use Disorder, run by Yale University at 4 sites 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 5 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: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

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 14 Feb 2024). 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?

Time Line Follow Back (TLFB) for Cannabis Use (time frame: Change from baseline in self reported cannabis use as measured by the TLFB approach at baseline and then weekly average daily use over 8 weeks.). The study lists 2 primary outcomes in all. 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 NCT03386487.

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 14 Feb 2024.