Trial Outcomes & Findings for N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence (NCT NCT00332605)

Last Updated: 2022-08-23

Results Overview

used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

beginning and at each visit until the end of their participation in the study

Results posted on

2022-08-23

Participant Flow

July 2006 - September 2009

Participant milestones

Participant milestones
Measure	Naltrexone Naltrexone tablets - 50mg pills taken by mouth daily	N-Acetyl Cysteine 600mg tablets taken by mouth daily	Placebo Inactive pill taken by mouth daily
Overall Study STARTED	14	14	17
Overall Study COMPLETED	12	12	9
Overall Study NOT COMPLETED	2	2	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone n=14 Participants Naltrexone tablets - 50mg pills taken by mouth daily	N-Acetyl Cysteine n=14 Participants 600mg tablets taken by mouth daily	Placebo n=17 Participants Inactive pill taken by mouth daily	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	45 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	37 years STANDARD_DEVIATION 8.2 • n=5 Participants	37.2 years STANDARD_DEVIATION 8.1 • n=7 Participants	36.1 years STANDARD_DEVIATION 6.6 • n=5 Participants	36.9 years STANDARD_DEVIATION 7.2 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants	30 Participants n=4 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	17 participants n=5 Participants	45 participants n=4 Participants

PRIMARY outcome

Timeframe: beginning and at each visit until the end of their participation in the study

Population: Reported scores are Mean and standard deviation for Subjects last visit (including last-observation carried forward).

used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Naltrexone n=14 Participants Naltrexone tablets	N-Acetyl Cysteine n=14 Participants 600mg tablets, daily	Placebo n=17 Participants Placebo capsules
Penn Craving Scale	24.0 units on a scale Standard Deviation 5.5	24.0 units on a scale Standard Deviation 5.4	21.1 units on a scale Standard Deviation 6.9

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

N-Acetyl Cysteine

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Naltrexone n=14 participants at risk Naltrexone tablets - 50mg pills taken by mouth daily	N-Acetyl Cysteine n=14 participants at risk 600mg tablets taken by mouth daily	Placebo n=17 participants at risk Inactive pill taken by mouth daily
Gastrointestinal disorders Nausea	57.1% 8/14 • Number of events 8	57.1% 8/14 • Number of events 8	41.2% 7/17 • Number of events 7
General disorders Lethargy	0.00% 0/14	0.00% 0/14	5.9% 1/17 • Number of events 1

Additional Information

Jon E. Grant

University of Chicago

Phone: 773-834-1325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place