N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

• ClinicalTrials.gov Identifier: NCT00332605
• Recruitment Status: Completed
• First Posted: June 1, 2006
• Results First Posted: July 24, 2013
• Last Update Posted: November 30, 2017
• Sponsor: University of Chicago
• Information provided by (Responsible Party): Jon Grant, University of Minnesota

Tracking Information

• First Submitted Date: May 30, 2006
• First Posted Date: June 1, 2006
• Results First Submitted Date: March 1, 2012
• Results First Posted Date: July 24, 2013
• Last Update Posted Date: November 30, 2017
• Study Start Date: June 2006
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2013)

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.

• Original Primary Outcome Measures (submitted: May 30, 2006): Penn Craving Scale
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: May 30, 2006): Urine toxicology screens
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Methamphetamine Dependence

Intervention

• Drug: Naltrexone plus N-Acetyl Cysteine
  daily
  Other Names:

  • Naltrexone:
  • Revia
• Drug: Placebo
  daily

Study Arms

• Experimental: Naltrexone plus N-Acetyl Cysteine

  Naltrexone tablets

  N-Acetyl Cysteine: 600mg tablets, daily

  Intervention: Drug: Naltrexone plus N-Acetyl Cysteine
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 18, 2013): 45
• Original Enrollment (submitted: May 30, 2006): 40
• Actual Study Completion Date: January 2010
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00332605
• Other Study ID Numbers: 0601M80486
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jon Grant, University of Minnesota
• Study Sponsor: University of Chicago
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Chicago
• Verification Date: October 2017