Trial Outcomes & Findings for Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal (NCT NCT01618656)
NCT ID: NCT01618656
Last Updated: 2023-02-23
Results Overview
32-item checklist evaluating potential symptoms of cannabis withdrawal, lower values reflect lesser severity of withdrawal symptoms (lower scores represent a better outcome). Min: 0 Max: 96
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
The MWC was administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (during the inpatient phase when withdrawal peaks) to assess change from baseline (Day 0). The scores from each time point and subject were calculated to report the mean score for each arm.
Results posted on
2023-02-23
Participant Flow
Participant milestones
| Measure |
PF-04457845 (4mg by Mouth Daily for 4 Weeks)
2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
PF-04457845: Study medication will be administered at 4mg by mouth daily for four weeks.
|
Placebo (Sugar Pill, by Mouth Daily for 4 Weeks)
1/3 of subjects will be randomized to placebo
Placebo: Sugar pill
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
24
|
|
Overall Study
COMPLETED
|
38
|
20
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
PF-04457845 (4mg by Mouth Daily for 4 Weeks)
2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
PF-04457845: Study medication will be administered at 4mg by mouth daily for four weeks.
|
Placebo (Sugar Pill, by Mouth Daily for 4 Weeks)
1/3 of subjects will be randomized to placebo
Placebo: Sugar pill
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
Baseline characteristics by cohort
| Measure |
PF-04457845 (4mg by Mouth Daily for 4 Weeks)
n=46 Participants
2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
PF-04457845: Study medication will be administered at 4mg by mouth daily for four weeks.
|
Placebo (Sugar Pill, by Mouth Daily for 4 Weeks)
n=24 Participants
1/3 of subjects will be randomized to placebo
Placebo: Sugar pill
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=113 Participants
|
24 Participants
n=163 Participants
|
70 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=113 Participants
|
24 Participants
n=163 Participants
|
70 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
11 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=113 Participants
|
20 Participants
n=163 Participants
|
59 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=113 Participants
|
12 Participants
n=163 Participants
|
36 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=113 Participants
|
9 Participants
n=163 Participants
|
27 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
6 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=113 Participants
|
24 Participants
n=163 Participants
|
70 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: The MWC was administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (during the inpatient phase when withdrawal peaks) to assess change from baseline (Day 0). The scores from each time point and subject were calculated to report the mean score for each arm.Population: Missing data and the removal of outliers led to differences between the total number of participants and the sample for this variable
32-item checklist evaluating potential symptoms of cannabis withdrawal, lower values reflect lesser severity of withdrawal symptoms (lower scores represent a better outcome). Min: 0 Max: 96
Outcome measures
| Measure |
PF-04457845 (4mg by Mouth Daily for 4 Weeks)
n=31 Participants
2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
PF-04457845: Study medication will be administered at 4mg by mouth daily for four weeks.
|
Placebo (Sugar Pill, by Mouth Daily for 4 Weeks)
n=19 Participants
1/3 of subjects will be randomized to placebo
Placebo: Sugar pill
|
|---|---|---|
|
Change in Marijuana Withdrawal Checklist (MWC)
|
6.04 score on a scale
Interval 4.43 to 8.24
|
11 score on a scale
Interval 7.78 to 15.57
|
PRIMARY outcome
Timeframe: Administered weekly for 4 weeks to assess change from baseline (Day 0). The scores from each time point and subject were calculated to report the mean score for each arm.Population: Missing data and the removal of outliers led to differences between the total number of participants and the sample for this variable
Subject quantifies and reports frequency of cannabis use prior to study participation and during the 4 week period. Lower scores reflect less cannabis usage, while higher scores reflect more frequent usage. Min: 0 Max: undeterminable, varies per patient and their usage.
Outcome measures
| Measure |
PF-04457845 (4mg by Mouth Daily for 4 Weeks)
n=32 Participants
2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
PF-04457845: Study medication will be administered at 4mg by mouth daily for four weeks.
|
Placebo (Sugar Pill, by Mouth Daily for 4 Weeks)
n=19 Participants
1/3 of subjects will be randomized to placebo
Placebo: Sugar pill
|
|---|---|---|
|
Change in Self Reported Cannabis Use at the End of 4 Weeks
|
0.40 joints per day
Interval 0.25 to 0.62
|
1.27 joints per day
Interval 0.82 to 1.97
|
PRIMARY outcome
Timeframe: Samples obtained weekly for 4 weeks to assess change from baseline (Day 0). The results from each time point and subject were calculated to report the mean score for each arm.Population: Missing data and the removal of outliers led to differences between the total number of participants and the sample for this variable
Subjects provide urine samples to quantify levels of THC.
Outcome measures
| Measure |
PF-04457845 (4mg by Mouth Daily for 4 Weeks)
n=31 Participants
2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
PF-04457845: Study medication will be administered at 4mg by mouth daily for four weeks.
|
Placebo (Sugar Pill, by Mouth Daily for 4 Weeks)
n=19 Participants
1/3 of subjects will be randomized to placebo
Placebo: Sugar pill
|
|---|---|---|
|
Change in THC-COOH Quantification at the End of 4 Weeks
|
265.55 ng/mL
Interval 175.6 to 401.57
|
657.92 ng/mL
Interval 381.6 to 1134.3
|
SECONDARY outcome
Timeframe: Polysomnography was collected two nights prior to baseline visit, for three nights during study treatment and two nights after four weeks of study treatment. A mean was calculated to assess change from baseline (Day 0).Population: The units analyzed reflects the number of data points (sum of participants per drug condition across time) was 42 in the placebo group and 82 in the PF-04457845 group. Missing data and the removal of outliers led to differences between the total number of participants and the sample for this variable.
Polysomnography (PSG) is a comprehensive reading of biophysiological changes that occur during sleep, including identification of sleep stage. A mean and standard deviation of their data points during sleep stages were calculated to determine change from baseline to the end of study treatment.
Outcome measures
| Measure |
PF-04457845 (4mg by Mouth Daily for 4 Weeks)
n=82 Number of Data Points
2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
PF-04457845: Study medication will be administered at 4mg by mouth daily for four weeks.
|
Placebo (Sugar Pill, by Mouth Daily for 4 Weeks)
n=42 Number of Data Points
1/3 of subjects will be randomized to placebo
Placebo: Sugar pill
|
|---|---|---|
|
Change in Polysomnography
|
89.56 minutes
Standard Deviation 35.20
|
69.29 minutes
Standard Deviation 27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (Once pre-treatment and during the inpatient phase 'acute abstinence') to assess change from baseline (Day 0)Visual analog scale for feeling states (depression, anxiety, irritability)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Samples obtained at the following study visits: Day -1, Day 0, Day 2, Day 4, Week 2, Week 3, Week 4 to assess change from baseline (Day 0)Measurement of circulating plasma Anandamide
Outcome measures
Outcome data not reported
Adverse Events
PF-04457845 (4mg by Mouth Daily for 4 Weeks)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo (Sugar Pill, by Mouth Daily for 4 Weeks)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-04457845 (4mg by Mouth Daily for 4 Weeks)
n=46 participants at risk
2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
PF-04457845: Study medication will be administered at 4mg by mouth daily for four weeks.
|
Placebo (Sugar Pill, by Mouth Daily for 4 Weeks)
n=24 participants at risk
1/3 of subjects will be randomized to placebo
Placebo: Sugar pill
|
|---|---|---|
|
Nervous system disorders
Headache
|
15.2%
7/46 • Number of events 12
|
20.8%
5/24 • Number of events 8
|
|
Nervous system disorders
Trouble Concentrating
|
0.00%
0/46
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/46
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Stuffy Nose
|
4.3%
2/46 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Sneezing
|
2.2%
1/46 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fluid Filled Cyst on Left Wrist
|
0.00%
0/46
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Chest Congestion
|
8.7%
4/46 • Number of events 4
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
2/46 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Red Marks/Skin Irritation at PSG Electrode Placement
|
2.2%
1/46 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash from Tape used for PSG Electrode Application
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Eye disorders
Eye Twitch
|
0.00%
0/46
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Lightheaded after Blood Draw
|
2.2%
1/46 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right Shoulder Pain
|
2.2%
1/46 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/46
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
Loose Stool
|
2.2%
1/46 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Gastric Paralysis
|
0.00%
0/46
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Chronic Gastritis
|
0.00%
0/46
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
High Blood Pressure
|
0.00%
0/46
|
4.2%
1/24 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/46
|
8.3%
2/24 • Number of events 2
|
|
Nervous system disorders
Syncopal Episode (Related to Phlebotomy)
|
0.00%
0/46
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Sleep Disturbances
|
0.00%
0/46
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Itchy Throat
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
6.5%
3/46 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Fever
|
4.3%
2/46 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Jammed Pinky Finger
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Feet Pain
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Upper Respiratory Infection
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Eye disorders
Scratched Cornea
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
|
4.3%
2/46 • Number of events 2
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Sharp Rib Pain
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Pressure in Head
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Sinus Pressure
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Tooth Pain
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Muscle Strain in Back
|
4.3%
2/46 • Number of events 2
|
0.00%
0/24
|
|
General disorders
Runny Nose
|
4.3%
2/46 • Number of events 2
|
0.00%
0/24
|
|
General disorders
Sore Throat
|
8.7%
4/46 • Number of events 4
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Dry Skin on Face
|
4.3%
2/46 • Number of events 2
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Foot Laceration
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Cyst Under Eye
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Swollen Lymph Node in Groin
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Lyme Disease
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Chest Tightness
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Feeling Faint
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Trouble Sleeping
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Concussion
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Ringworm
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Vascular disorders
Low Phosphorus Levels
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Ear and labyrinth disorders
Ear Popping
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Worsening of Existing Hernia
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Nose Bleed
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gas
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Eye disorders
Burst Blood Vessel in Right Eye
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Sweating
|
2.2%
1/46 • Number of events 1
|
0.00%
0/24
|
Additional Information
Deepak Cyril D'Souza, MD
Yale University School of Medicine
Phone: 203-932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place