N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence
A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2006
CompletedFirst Posted
Study publicly available on registry
June 1, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
July 24, 2013
CompletedAugust 23, 2022
July 1, 2022
3.5 years
May 30, 2006
March 1, 2012
July 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Penn Craving Scale
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.
beginning and at each visit until the end of their participation in the study
Study Arms (2)
Naltrexone plus N-Acetyl Cysteine
EXPERIMENTALNaltrexone tablets N-Acetyl Cysteine: 600mg tablets, daily
Placebo
PLACEBO COMPARATORInactive placebo ("sugar pill")
Interventions
daily
Eligibility Criteria
You may qualify if:
- men and women age 18-65
- current DSM-IV methamphetamine dependence.
You may not qualify if:
- unstable medical illness
- history of seizures
- myocardial infarction within 6 months
- current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- any thoughts of suicide
- lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder
- previous treatment with N-Acetyl Cysteine or naltrexone
- 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
- abnormal liver function tests at screening
- diagnosis of asthma
- current use of opiates.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jon E. Grant
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Jon E Grant, MD, JD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2006
First Posted
June 1, 2006
Study Start
June 1, 2006
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
August 23, 2022
Results First Posted
July 24, 2013
Record last verified: 2022-07