Methamphetamine Dependence
Conditions
Keywords
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.
Interventions
DRUGNaltrexone plus N-Acetyl Cysteine
daily
DRUGPlacebo
daily
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
July 2006 - September 2009
Participants by arm
| Arm | Count |
|---|---|
| Naltrexone Naltrexone tablets - 50mg pills taken by mouth daily | 14 |
| N-Acetyl Cysteine 600mg tablets taken by mouth daily | 14 |
| Placebo Inactive pill taken by mouth daily | 17 |
| Total | 45 |
Baseline characteristics
| Characteristic | N-Acetyl Cysteine | Placebo | Naltrexone | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 17 Participants | 14 Participants | 45 Participants |
| Age, Continuous | 37.2 years STANDARD_DEVIATION 8.1 | 36.1 years STANDARD_DEVIATION 6.6 | 37 years STANDARD_DEVIATION 8.2 | 36.9 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 14 participants | 17 participants | 14 participants | 45 participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 8 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 14 | 8 / 14 | 7 / 17 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 17 |
Outcome results
Primary
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naltrexone | Penn Craving Scale | 24.0 units on a scale | Standard Deviation 5.5 |
| N-Acetyl Cysteine | Penn Craving Scale | 24.0 units on a scale | Standard Deviation 5.4 |
| Placebo | Penn Craving Scale | 21.1 units on a scale | Standard Deviation 6.9 |