Trial Outcomes & Findings for Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals (NCT NCT00497055)
NCT ID: NCT00497055
Last Updated: 2014-03-24
Results Overview
To test the hypothesis that aripiprazole 20 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent individuals, as determined by the proportion of methamphetamine-positive urines in the aripiprazole versus placebo group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Final study visit at week 12
Results posted on
2014-03-24
Participant Flow
Participant milestones
| Measure |
Aripiprazole
Aripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve.
|
Placebo
Placebo (for Aripiprazole) 5mg daily for week one. Placebo (for Aripiprazole) 10mg daily for week two. Placebo (for Aripiprazole) 20mg daily for weeks three through twelve.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
35
|
40
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=45 Participants
aripiprazole daily for 3 months
|
Placebo
n=45 Participants
placebo daily for 3 months
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
40 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Final study visit at week 12To test the hypothesis that aripiprazole 20 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent individuals, as determined by the proportion of methamphetamine-positive urines in the aripiprazole versus placebo group.
Outcome measures
| Measure |
Aripiprazole
n=45 Participants
aripiprazole daily for 3 months
|
Placebo
n=45 Participants
placebo daily for 3 months
|
|---|---|---|
|
To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.
|
44 perc of positive urines at final visit
|
40 perc of positive urines at final visit
|
PRIMARY outcome
Timeframe: Adherence as determined by MEMS (throughout study, up to 12 weeks)To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps \[MEMS or Medication Event Monitoring System\]) medication adherence to aripiprazole and placebo. (Percent adherence from MEMS is determined by 100\* the number of days where MEMS registered an opening out of the number of days a dose was prescribed for each arm.)
Outcome measures
| Measure |
Aripiprazole
n=45 Participants
aripiprazole daily for 3 months
|
Placebo
n=45 Participants
placebo daily for 3 months
|
|---|---|---|
|
To Measure the Acceptability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, by Determining (Via Electronic Pill Caps [MEMS or Medication Event Monitoring System]) Medication Adherence to Aripiprazole and Placebo.
|
46 percent adherence from MEMS
Standard Deviation 32
|
39 percent adherence from MEMS
Standard Deviation 27
|
PRIMARY outcome
Timeframe: Total reported adverse events (throughout study, up to 12 weeks)Outcome measures
| Measure |
Aripiprazole
n=45 Participants
aripiprazole daily for 3 months
|
Placebo
n=45 Participants
placebo daily for 3 months
|
|---|---|---|
|
To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms.
|
156 total reported adverse events
|
144 total reported adverse events
|
Adverse Events
Aripiprazole
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole
n=45 participants at risk
aripiprazole daily for 3 months
|
Placebo
n=45 participants at risk
placebo daily for 3 months
|
|---|---|---|
|
Renal and urinary disorders
rhabdomyolysis
|
2.2%
1/45
|
0.00%
0/45
|
|
Vascular disorders
subdural hematoma
|
0.00%
0/45
|
2.2%
1/45
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastatic cancer
|
0.00%
0/45
|
2.2%
1/45
|
|
Skin and subcutaneous tissue disorders
abscess
|
0.00%
0/45
|
4.4%
2/45
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
2.2%
1/45
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
2.2%
1/45
|
0.00%
0/45
|
Other adverse events
| Measure |
Aripiprazole
n=45 participants at risk
aripiprazole daily for 3 months
|
Placebo
n=45 participants at risk
placebo daily for 3 months
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Abrasions
|
6.7%
3/45
|
2.2%
1/45
|
|
Nervous system disorders
Akathisia
|
26.7%
12/45
|
4.4%
2/45
|
|
Skin and subcutaneous tissue disorders
Abscess
|
2.2%
1/45
|
8.9%
4/45
|
|
Skin and subcutaneous tissue disorders
Contusion
|
2.2%
1/45
|
8.9%
4/45
|
|
General disorders
Drowsiness
|
13.3%
6/45
|
0.00%
0/45
|
|
General disorders
Fatigue
|
17.8%
8/45
|
0.00%
0/45
|
|
General disorders
Hyperbilirubinemia
|
6.7%
3/45
|
8.9%
4/45
|
|
General disorders
Toothache
|
6.7%
3/45
|
8.9%
4/45
|
|
General disorders
Viral Syndrome
|
2.2%
1/45
|
6.7%
3/45
|
|
Nervous system disorders
Anxiety
|
0.00%
0/45
|
6.7%
3/45
|
|
Psychiatric disorders
Depressed Mood
|
6.7%
3/45
|
2.2%
1/45
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.2%
1/45
|
8.9%
4/45
|
|
Nervous system disorders
Headache
|
4.4%
2/45
|
6.7%
3/45
|
|
General disorders
Hypernatremia
|
8.9%
4/45
|
0.00%
0/45
|
|
General disorders
Hypocalcemia
|
6.7%
3/45
|
4.4%
2/45
|
|
General disorders
Increased Alanine Transaminase (ALT)
|
17.8%
8/45
|
15.6%
7/45
|
|
General disorders
Increased Aspartate Transaminase (AST)
|
13.3%
6/45
|
8.9%
4/45
|
|
Skin and subcutaneous tissue disorders
Laceration
|
0.00%
0/45
|
6.7%
3/45
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45
|
6.7%
3/45
|
|
Nervous system disorders
Restlessness
|
8.9%
4/45
|
2.2%
1/45
|
|
Infections and infestations
Skin and soft tissue infection
|
6.7%
3/45
|
11.1%
5/45
|
|
Nervous system disorders
Sleep Disturbance
|
6.7%
3/45
|
4.4%
2/45
|
|
General disorders
Sweats
|
0.00%
0/45
|
8.9%
4/45
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection (URI)
|
13.3%
6/45
|
8.9%
4/45
|
|
Renal and urinary disorders
Urinary Tract Infection (UTI)
|
0.00%
0/45
|
6.7%
3/45
|
Additional Information
Phillip O. Coffin, Director of Substance Use Research
San Francisco Department of Public Health
Phone: 415-437-6282
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place