N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00332605
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in combination with naltrexone in methamphetamine dependence.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence	Drug: Naltrexone plus N-Acetyl Cysteine; Drug: Placebo	Phase 2

Detailed Description

Forty subjects with DSM-IV methamphetamine dependence will receive 8 weeks of double-blind combination medication (NAC plus naltrexone) or placebo. The hypothesis to be tested is that NAC plus naltrexone will be effective and well tolerated in patients with methamphetamine dependence compared to placebo. The proposed study will provide needed data on the treatment of a public health crisis that currently lacks a clearly effective treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Naltrexone plus N-Acetyl Cysteine Naltrexone tablets N-Acetyl Cysteine: 600mg tablets, daily	Drug: Naltrexone plus N-Acetyl Cysteine; daily; Other Names: Naltrexone: Revia
Placebo Comparator: Placebo	Drug: Placebo; daily

Outcome Measures

Primary Outcome Measures

1. Penn Craving Scale [beginning and at each visit until the end of their participation in the study]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. men and women age 18-65

2. current DSM-IV methamphetamine dependence.

Exclusion Criteria:

1. unstable medical illness

2. history of seizures

3. myocardial infarction within 6 months

4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential

5. any thoughts of suicide

6. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder

7. previous treatment with N-Acetyl Cysteine or naltrexone

8. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline

9. abnormal liver function tests at screening

10. diagnosis of asthma

11. current use of opiates.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

• Principal Investigator: Jon E Grant, MD, JD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jon Grant, Professor of Psychiatry, University of Minnesota
• ClinicalTrials.gov Identifier: NCT00332605
• Other Study ID Numbers: 0601M80486
• First Posted: Jun 1, 2006
• Last Update Posted: Nov 30, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Jon Grant, Professor of Psychiatry, University of Minnesota: Methamphetamine Dependence
• Additional relevant MeSH terms: Acetylcysteine; Naltrexone; N-monoacetylcystine

Study Results

Participant Flow

Recruitment Details	July 2006 - September 2009

Arm/Group Title	Naltrexone	N-Acetyl Cysteine	Placebo
Arm/Group Description	Naltrexone tablets - 50mg pills taken by mouth daily	600mg tablets taken by mouth daily
Period Title: Overall Study
STARTED	14	14	17
COMPLETED	12	12	9
NOT COMPLETED	2	2	8

Baseline Characteristics

Arm/Group Title	Naltrexone	N-Acetyl Cysteine	Placebo	Total
Arm/Group Description	Naltrexone tablets - 50mg pills taken by mouth daily	600mg tablets taken by mouth daily	Total of all reporting groups
Overall Participants	14	14	17	45
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	14 100%	14 100%	17 100%	45 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37 (8.2)	37.2 (8.1)	36.1 (6.6)	36.9 (7.2)
Sex: Female, Male (Count of Participants)
Female	6 42.9%	6 42.9%	3 17.6%	15 33.3%
Male	8 57.1%	8 57.1%	14 82.4%	30 66.7%
Region of Enrollment (participants) [Number]
United States	14 100%	14 100%	17 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Penn Craving Scale
Description	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.
Time Frame	beginning and at each visit until the end of their participation in the study

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Naltrexone	N-Acetyl Cysteine	Placebo
Arm/Group Description	Naltrexone tablets	600mg tablets, daily	Placebo capsules
Measure Participants	14	14	17
Mean (Standard Deviation) [units on a scale]	24.0 (5.5)	24.0 (5.4)	21.1 (6.9)

Adverse Events

Arm/Group Title	Naltrexone		N-Acetyl Cysteine		Placebo
Arm/Group Description	Naltrexone tablets - 50mg pills taken by mouth daily		600mg tablets taken by mouth daily
All Cause Mortality
	Naltrexone		N-Acetyl Cysteine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Naltrexone		N-Acetyl Cysteine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Naltrexone		N-Acetyl Cysteine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/14 (57.1%)		8/14 (57.1%)		7/17 (41.2%)
Gastrointestinal disorders
Nausea	8/14 (57.1%)	8	8/14 (57.1%)	8	7/17 (41.2%)	7
General disorders
Lethargy	0/14 (0%)	0	0/14 (0%)	0	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.