Methamphetamine Dependence, Methamphetamine Withdrawal
Conditions
Keywords
methamphetamine, drug abuse, withdrawal
Brief summary
Methamphetamine use has escalated in recent years. Methamphetamine use has also spread throughout the country. Although much information has been gathered on the treatment of cocaine abuse, very little information has been obtained on the treatment of methamphetamine abuse. One of the first steps in developing appropriate treatment is to examine the effects of stopping a particular substance's use on individuals abusing that substance. To date this has not been well studied for people abusing methamphetamine. The purpose of this study is to better understand and develop accurate ways of measuring symptoms associated with stopping the use of methamphetamine in people that are abusing methamphetamine. If the withdrawal symptoms are able to be effectively measured, this will help to develop treatments targeted at alleviating these symptoms. These symptoms are often associated with relapse to use of that substance.
Detailed description
The primary aim of this 4 week observational study is to examine and characterize the withdrawal symptoms experienced by methamphetamine abusers who are recently abstinent from methamphetamine. The period of drug or substance withdrawal is often cited as the time during which risk of relapse use of that substance is very high. Therefore it is highly important to characterize specifically the withdrawal syndrome associated with cessation of methamphetamine use. This study will demonstrate our ability to recruit and work with this methamphetamine dependent population. In addition it will allow for the collection of pilot data to assist in selecting appropriate assessment tools in a submission of an RO1 grant for well-controlled studies characterizing methamphetamine withdrawal.
Interventions
None listed
Sponsors
University of Arkansas
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 years old * Subjects must have a history of methamphetamine use, with recent use verified by a urine toxicology screen positive for amphetamines
Exclusion criteria
* Current diagnosis of drug or alcohol physical dependence (other than methamphetamine or tobacco) * Schizophrenia, or bipolar type I disorder * Present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that may affect mood ratings * Current suicidality or psychosis * Pregnancy: hormonal changes during pregnancy can affect mood which might produce a potential confound if pregnant women were enrolled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Methamphetamine Selective Severity Assessment (MSSA) | Baseline through week 4 | Methamphetamine Selective Severity Assessment (MSSA) is an 18 item questionnaire assessing withdrawal symptoms with each question measured on a scale from 0(best score)-7(worst score) for a range in scores from 0(best score)-126(worst score). Higher scores indicate more severe withdrawal symptoms. |
| Methamphetamine Withdrawal Assessment (MAWA) | Baseline through week 4 | The Methamphetamine Withdrawal Assessment (MAWA) is a 13 item questionnaire which measures symptoms of methamphetamine withdrawal on a scale from 0(best score)-4(worst score). The total score ranges from 0(best score)-52(worst score). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D) Rating Score | 4 weeks | Hamilton Depression rating scale (HAM-D)is a scale that covers 21 symptoms with a total score of 0(best score)-62 (worst score) and a cutoff for moderate depression of 15 or above. |
Countries
United States
Participant flow
Recruitment details
A total of 13 participants were recruited for enrollment in study entry.
Pre-assignment details
A total of 5 participants did not meet study criteria and did not enter the study proper, leaving a total of 8 eligible subjects.
Participants by arm
| Arm | Count |
|---|---|
| Methamphetamine Dependent Methamphetamine dependent participants admitted to Recovery Centers of Arkansas | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Methamphetamine Dependent |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 32.67 years STANDARD_DEVIATION 5.8 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Methamphetamine Selective Severity Assessment (MSSA)
Methamphetamine Selective Severity Assessment (MSSA) is an 18 item questionnaire assessing withdrawal symptoms with each question measured on a scale from 0(best score)-7(worst score) for a range in scores from 0(best score)-126(worst score). Higher scores indicate more severe withdrawal symptoms.
Time frame: Baseline through week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methamphetamine Dependent | Methamphetamine Selective Severity Assessment (MSSA) | 48.2 units on a scale | Standard Deviation 26.8 |
Comparison: Means and ranges were computed for the continuous baseline characteristics.For data with 5 time points (baseline and weeks 1 through 4), hypothesis tests were performed to test for a differences between baseline and each subsequent time point as well as differences between each time point For data with 3 time points hypothesis tests were performed to test for a differences between baseline and wk 2, wk 2 and wk 4, as well as between baseline and wk 4.p-value: <0.05Mixed Models Analysis
Primary
Methamphetamine Withdrawal Assessment (MAWA)
The Methamphetamine Withdrawal Assessment (MAWA) is a 13 item questionnaire which measures symptoms of methamphetamine withdrawal on a scale from 0(best score)-4(worst score). The total score ranges from 0(best score)-52(worst score).
Time frame: Baseline through week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methamphetamine Dependent | Methamphetamine Withdrawal Assessment (MAWA) | 20.3 Units on a scale | Standard Deviation 12.5 |
Comparison: Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.p-value: <0.05Mixed Models Analysis
Secondary
Hamilton Depression Rating Scale (HAM-D) Rating Score
Hamilton Depression rating scale (HAM-D)is a scale that covers 21 symptoms with a total score of 0(best score)-62 (worst score) and a cutoff for moderate depression of 15 or above.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methamphetamine Dependent | Hamilton Depression Rating Scale (HAM-D) Rating Score | 18.5 Units on a scale | Standard Deviation 13.4 |
Comparison: Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.p-value: <0.05Mixed Models Analysis