Trial Outcomes & Findings for Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study (NCT NCT00653263)
NCT ID: NCT00653263
Last Updated: 2021-06-28
Results Overview
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.
COMPLETED
8 participants
Baseline through week 4
2021-06-28
Participant Flow
A total of 13 participants were recruited for enrollment in study entry.
A total of 5 participants did not meet study criteria and did not enter the study proper, leaving a total of 8 eligible subjects.
Participant milestones
| Measure |
Methamphetamine Dependent
Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Methamphetamine Dependent
Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
Baseline characteristics by cohort
| Measure |
Methamphetamine Dependent
n=8 Participants
Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
32.67 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline through week 4Methamphetamine 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.
Outcome measures
| Measure |
Methamphetamine Dependent
n=6 Participants
Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
|
|---|---|
|
Methamphetamine Selective Severity Assessment (MSSA)
|
48.2 "units on a scale"
Standard Deviation 26.8
|
PRIMARY outcome
Timeframe: Baseline through week 4The 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).
Outcome measures
| Measure |
Methamphetamine Dependent
n=6 Participants
Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
|
|---|---|
|
Methamphetamine Withdrawal Assessment (MAWA)
|
20.3 "Units on a scale"
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 4 weeksHamilton 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.
Outcome measures
| Measure |
Methamphetamine Dependent
n=6 Participants
Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
|
|---|---|
|
Hamilton Depression Rating Scale (HAM-D) Rating Score
|
18.5 "Units on a scale"
Standard Deviation 13.4
|
Adverse Events
Methamphetamine Dependent
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place