Trial Outcomes & Findings for Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana (NCT NCT00403117)

Results Overview

All subjective effects were measured using visual analog scales (VAS), a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to rate their subjective experiences on the line according to how they felt at that particular moment. Subjective assessments included measures of perceived marijuana strength, marijuana "high", "good effects" of marijuana, and how much marijuana was "liked". Marijuana's effects were determined by comparing the active and inactive marijuana conditions when paired with the placebo naltrexone condition (one comparison). Naltrexone's intrinsic effects were assessed by comparing placebo and each active dose of naltrexone (12, 25, 50, and 100 mg) under the inactive marijuana condition (four comparisons). Finally, the active marijuana- placebo naltrexone condition was compared to the active marijuana-active naltrexone conditions (four comparisons)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

Baseline compared to 6 week timepoint

Results posted on

2018-03-15

Participant Flow

A total of 15 males and 14 females completed this study, which used a within-subject design such that each participant received 10 different drug treatments/interventions in total.

Participant milestones

Participant milestones
Measure	Overall Study Participant Flow Of the 49 participants enrolled, only 29 completed all 10 drug interventions.
Overall Study STARTED	49
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Number of Baseline Participants n=29 Participants Baseline measures are only reported for the 29 participants who completed the study.
Age, Categorical <=18 years	0 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=113 Participants
Age, Categorical >=65 years	0 Participants n=113 Participants
Age, Continuous	28.0 Years STANDARD_DEVIATION 1.0 • n=113 Participants
Sex: Female, Male Female	14 Participants n=113 Participants
Sex: Female, Male Male	15 Participants n=113 Participants
Region of Enrollment United States	29 Participants n=113 Participants

PRIMARY outcome

Timeframe: Baseline compared to 6 week timepoint

Population: Data from 29 participants were included in this analysis.

All subjective effects were measured using visual analog scales (VAS), a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to rate their subjective experiences on the line according to how they felt at that particular moment. Subjective assessments included measures of perceived marijuana strength, marijuana "high", "good effects" of marijuana, and how much marijuana was "liked". Marijuana's effects were determined by comparing the active and inactive marijuana conditions when paired with the placebo naltrexone condition (one comparison). Naltrexone's intrinsic effects were assessed by comparing placebo and each active dose of naltrexone (12, 25, 50, and 100 mg) under the inactive marijuana condition (four comparisons). Finally, the active marijuana- placebo naltrexone condition was compared to the active marijuana-active naltrexone conditions (four comparisons)

Outcome measures

Outcome measures
Measure	Placebo + Marijuana (0.0%THC) n=29 Participants Placebo + Marijuana (0.0%THC)	Placebo + Marijuana (3.27% THC) n=29 Participants Placebo + Marijuana (3.27% THC)	Naltrexone (12mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (12mg) + marijuana (0.0%THC)	Naltrexone (12mg) + Marijuana (3.27%THC) n=29 Participants Naltrexone (12mg) + marijuana (3.27%THC)	Naltrexone (25mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (25mg) + marijuana (0.0%THC)	Naltrexone (25mg) + Marijuana (3.27%THC) n=29 Participants Naltrexone (25mg) + marijuana (3.27%THC)	Naltrexone (50mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (50mg) + marijuana (0.0%THC)	Naltrexone (50mg) + Marijuana (3.27%THC) n=29 Participants Naltrexone (50mg) + marijuana (3.27%THC)	Naltrexone (100mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (100mg) + marijuana (0.0%THC)	Naltrexone (100mg) + Marijuana (3.27%THC) n=29 Participants naltrexone + active marijuana
Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. Mean VAS ratings "Marijuana Strength"	8.0 units on a scale Standard Deviation 0.8	25.0 units on a scale Standard Deviation 3.2	6.7 units on a scale Standard Deviation 0.9	34.0 units on a scale Standard Deviation 2.1	8.1 units on a scale Standard Deviation 0.6	31.6 units on a scale Standard Deviation 1.1	9.7 units on a scale Standard Deviation 0.7	36.2 units on a scale Standard Deviation 2.3	10.1 units on a scale Standard Deviation 0.9	34.5 units on a scale Standard Deviation 1.4
Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. Mean VAS ratings "High"	4.1 units on a scale Standard Deviation 0.7	11.0 units on a scale Standard Deviation 1.1	3.7 units on a scale Standard Deviation 0.6	23.0 units on a scale Standard Deviation 3.2	3.0 units on a scale Standard Deviation 0.6	20.4 units on a scale Standard Deviation 2.2	4.0 units on a scale Standard Deviation 0.3	22.2 units on a scale Standard Deviation 1.7	3.9 units on a scale Standard Deviation 0.3	21.3 units on a scale Standard Deviation 2.4
Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. Mean VAS ratings "Good Effect"	10.0 units on a scale Standard Deviation 1.1	38.3 units on a scale Standard Deviation 4.5	6.8 units on a scale Standard Deviation 1.2	43.1 units on a scale Standard Deviation 5.7	9.0 units on a scale Standard Deviation 0.8	44.1 units on a scale Standard Deviation 5.0	10.2 units on a scale Standard Deviation 1.1	42.2 units on a scale Standard Deviation 4.2	12.5 units on a scale Standard Deviation 0.9	44.0 units on a scale Standard Deviation 4.8
Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. Mean VAS ratings "Like Drug"	11.3 units on a scale Standard Deviation 1.2	35.0 units on a scale Standard Deviation 5.3	7.0 units on a scale Standard Deviation 0.7	44.0 units on a scale Standard Deviation 3.7	9.3 units on a scale Standard Deviation 1.2	34.7 units on a scale Standard Deviation 4.8	10.3 units on a scale Standard Deviation 0.5	38.0 units on a scale Standard Deviation 6.6	11.4 units on a scale Standard Deviation 1.2	44.0 units on a scale Standard Deviation 6.0

PRIMARY outcome

Timeframe: Baseline compared to 6 week timepoint

Population: Data from 29 participants were included in this analysis

Change in Digit Symbol Substitution Test (DSST) scores. Increasing scores indicate improvement, on a scale of 0-90. The task batteries included total correct attempts on a 3-min DSST.

Outcome measures

Outcome measures
Measure	Placebo + Marijuana (0.0%THC) n=29 Participants Placebo + Marijuana (0.0%THC)	Placebo + Marijuana (3.27% THC) n=29 Participants Placebo + Marijuana (3.27% THC)	Naltrexone (12mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (12mg) + marijuana (0.0%THC)	Naltrexone (12mg) + Marijuana (3.27%THC) n=29 Participants Naltrexone (12mg) + marijuana (3.27%THC)	Naltrexone (25mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (25mg) + marijuana (0.0%THC)	Naltrexone (25mg) + Marijuana (3.27%THC) n=29 Participants Naltrexone (25mg) + marijuana (3.27%THC)	Naltrexone (50mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (50mg) + marijuana (0.0%THC)	Naltrexone (50mg) + Marijuana (3.27%THC) n=29 Participants Naltrexone (50mg) + marijuana (3.27%THC)	Naltrexone (100mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (100mg) + marijuana (0.0%THC)	Naltrexone (100mg) + Marijuana (3.27%THC) n=29 Participants naltrexone + active marijuana
Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose	86.2 units on a scale Standard Error 1.8	86.1 units on a scale Standard Error 1.7	86.7 units on a scale Standard Error 1.7	84.7 units on a scale Standard Error 1.6	83.4 units on a scale Standard Error 1.7	83.5 units on a scale Standard Error 1.6	83.6 units on a scale Standard Error 1.8	82.1 units on a scale Standard Error 1.4	82.1 units on a scale Standard Error 1.6	83.0 units on a scale Standard Error 1.7

PRIMARY outcome

Timeframe: Baseline compared to 6 week timepoint

Population: A total of 29 participants were included in the final analysis

Change in mean heart rate as a function of marijuana and naltrexone dose

Outcome measures

Outcome measures
Measure	Placebo + Marijuana (0.0%THC) n=29 Participants Placebo + Marijuana (0.0%THC)	Placebo + Marijuana (3.27% THC) n=29 Participants Placebo + Marijuana (3.27% THC)	Naltrexone (12mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (12mg) + marijuana (0.0%THC)	Naltrexone (12mg) + Marijuana (3.27%THC) n=29 Participants Naltrexone (12mg) + marijuana (3.27%THC)	Naltrexone (25mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (25mg) + marijuana (0.0%THC)	Naltrexone (25mg) + Marijuana (3.27%THC) n=29 Participants Naltrexone (25mg) + marijuana (3.27%THC)	Naltrexone (50mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (50mg) + marijuana (0.0%THC)	Naltrexone (50mg) + Marijuana (3.27%THC) n=29 Participants Naltrexone (50mg) + marijuana (3.27%THC)	Naltrexone (100mg) + Marijuana (0.0%THC) n=29 Participants Naltrexone (100mg) + marijuana (0.0%THC)	Naltrexone (100mg) + Marijuana (3.27%THC) n=29 Participants naltrexone + active marijuana
Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.	68.5 Heart rate (beats/minute) Standard Deviation 0.5	70.7 Heart rate (beats/minute) Standard Deviation 0.6	65.8 Heart rate (beats/minute) Standard Deviation 0.5	72.1 Heart rate (beats/minute) Standard Deviation 0.4	67.3 Heart rate (beats/minute) Standard Deviation 0.4	72.7 Heart rate (beats/minute) Standard Deviation 0.7	65.6 Heart rate (beats/minute) Standard Deviation 0.3	72.2 Heart rate (beats/minute) Standard Deviation 0.6	67.7 Heart rate (beats/minute) Standard Deviation 0.4	72.4 Heart rate (beats/minute) Standard Deviation 0.4

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo + Inactive Marijuana (0.0%THC) n=49 participants at risk In this arm, participants received placebo + inactive marijuana (0.0%THC)	Placebo + Marijuana (3.27% THC) n=49 participants at risk In this arm, participants received placebo + Marijuana (3.27% THC)	Naltrexone (12mg) + Marijuana (0.0%THC) n=49 participants at risk In this arm, participants received naltrexone (12mg) + marijuana (0.0%THC)	Naltrexone (12mg) + Marijuana (3.27%THC) n=49 participants at risk In this arm, participants received naltrexone (12mg) + marijuana (3.27%THC)	Naltrexone (25mg) + Marijuana (0.0%THC) n=49 participants at risk In this arm, participants received naltrexone (25mg) + marijuana (0.0%THC)	Naltrexone (25mg) + Marijuana (3.27%THC) n=49 participants at risk In this arm, participants received naltrexone (25mg) + marijuana (3.27%THC)	Naltrexone (50mg) + Marijuana (0.0%THC) n=49 participants at risk In this arm, participants received naltrexone (50mg) + marijuana (0.0%THC)	Naltrexone (50mg) + Marijuana (3.27%THC) n=49 participants at risk In this arm, participants received naltrexone (50mg) + marijuana (3.27%THC)	Naltrexone (100mg) + Marijuana (0.0%THC) n=49 participants at risk In this arm, participants received naltrexone (100mg) + marijuana (0.0%THC)	Naltrexone (100mg) + Marijuana (3.27%THC) n=49 participants at risk In this arm, participants received naltrexone (100mg) + marijuana (3.27%THC)
Gastrointestinal disorders gastrointestinal upset	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	12.2% 6/49 • Number of events 6 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	2.0% 1/49 • Number of events 1 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.
Social circumstances conflicting social circumstance	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	14.3% 7/49 • Number of events 7 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	12.2% 6/49 • Number of events 6 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.	0.00% 0/49 • Adverse events were collected for the six weeks that each participant was enrolled in the study.

Additional Information

Margaret Haney, PhD

New York State Psychiatric Institute

Phone: 646-774-6153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place