Trial Outcomes & Findings for Study of Medical Treatment for Methamphetamine Addiction (NCT NCT00833443)
NCT ID: NCT00833443
Last Updated: 2014-02-26
Results Overview
The mean number of methamphetamine-free urine drug screens provided by participants in each group (range 0-36)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-02-26
Participant Flow
Participants were recruited via advertisements and outreach in the Los Angeles area
Participant milestones
| Measure |
Bupropion
Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
Sugar Pill
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
|
Overall Study
COMPLETED
|
21
|
15
|
|
Overall Study
NOT COMPLETED
|
20
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Medical Treatment for Methamphetamine Addiction
Baseline characteristics by cohort
| Measure |
Bupropion
n=41 Participants
Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
Sugar Pill
n=43 Participants
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
43 participants
n=7 Participants
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe mean number of methamphetamine-free urine drug screens provided by participants in each group (range 0-36)
Outcome measures
| Measure |
Bupropion
n=41 Participants
Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
Sugar Pill
n=43 Participants
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
|---|---|---|
|
Treatment Effectiveness Score
|
16.1 urine drug screens
Standard Deviation 12.7
|
10.6 urine drug screens
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: 12 weeksMethamphetamine abstinence confirmed via urine drug screens during the final two weeks of treatment (weeks 11 and 12)
Outcome measures
| Measure |
Bupropion
n=41 Participants
Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
Sugar Pill
n=43 Participants
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
|---|---|---|
|
End of Treatment Methamphetamine Abstinence
|
12 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Bupropion
n=41 Participants
Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
Sugar Pill
n=43 Participants
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
|---|---|---|
|
Treatment Retention
|
61.0 days
Standard Deviation 28.8
|
49.5 days
Standard Deviation 31.7
|
POST_HOC outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Bupropion
n=13 Participants
Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
Sugar Pill
n=28 Participants
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
|---|---|---|
|
End of Treatment Methamphetamine Abstinence
|
7 participants
|
5 participants
|
Adverse Events
Bupropion
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupropion
n=41 participants at risk
Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
Sugar Pill
n=43 participants at risk
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
2.4%
1/41 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
Cardiac disorders
Chest pain
|
2.4%
1/41 • Number of events 1
|
0.00%
0/43
|
|
Infections and infestations
Liver abscess
|
0.00%
0/41
|
2.3%
1/43 • Number of events 1
|
Other adverse events
| Measure |
Bupropion
n=41 participants at risk
Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
Sugar Pill
n=43 participants at risk
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
22.0%
9/41
|
14.0%
6/43
|
|
Psychiatric disorders
"Amped up"
|
14.6%
6/41
|
4.7%
2/43
|
|
Psychiatric disorders
Depressed mood
|
12.2%
5/41
|
7.0%
3/43
|
|
Nervous system disorders
Headache
|
12.2%
5/41
|
2.3%
1/43
|
|
Gastrointestinal disorders
Diarrhea
|
9.8%
4/41
|
0.00%
0/43
|
|
Gastrointestinal disorders
Dry mouth
|
7.3%
3/41
|
4.7%
2/43
|
|
Gastrointestinal disorders
Nausea/vomiting
|
7.3%
3/41
|
2.3%
1/43
|
|
Nervous system disorders
Dizziness
|
4.9%
2/41
|
2.3%
1/43
|
|
Cardiac disorders
Elevated blood pressure
|
4.9%
2/41
|
0.00%
0/43
|
|
Nervous system disorders
Muscle twitching
|
4.9%
2/41
|
0.00%
0/43
|
|
Psychiatric disorders
Panic attack
|
4.9%
2/41
|
2.3%
1/43
|
|
Psychiatric disorders
Paranoia
|
4.9%
2/41
|
0.00%
0/43
|
|
Psychiatric disorders
Vivid dreams/nightmares
|
4.9%
2/41
|
0.00%
0/43
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place