N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence
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ClinicalTrials.gov Identifier: NCT00332605 |
Recruitment Status :
Completed
First Posted : June 1, 2006
Results First Posted : July 24, 2013
Last Update Posted : November 30, 2017
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Sponsor:
University of Chicago
Information provided by (Responsible Party):
Jon Grant, University of Minnesota
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Tracking Information | ||||
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First Submitted Date ICMJE | May 30, 2006 | |||
First Posted Date ICMJE | June 1, 2006 | |||
Results First Submitted Date ICMJE | March 1, 2012 | |||
Results First Posted Date ICMJE | July 24, 2013 | |||
Last Update Posted Date | November 30, 2017 | |||
Study Start Date ICMJE | June 2006 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Penn Craving Scale [ Time Frame: 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.
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Original Primary Outcome Measures ICMJE |
Penn Craving Scale | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE |
Urine toxicology screens | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence | |||
Official Title ICMJE | A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence | |||
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. | |||
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Methamphetamine Dependence | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
45 | |||
Original Enrollment ICMJE |
40 | |||
Actual Study Completion Date ICMJE | January 2010 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00332605 | |||
Other Study ID Numbers ICMJE | 0601M80486 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Jon Grant, University of Minnesota | |||
Study Sponsor ICMJE | University of Chicago | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of Chicago | |||
Verification Date | October 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |