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Trial record 28 of 408 for:    ARIPIPRAZOLE

Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00497055
Recruitment Status : Completed
First Posted : July 6, 2007
Results First Posted : March 24, 2014
Last Update Posted : March 24, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Substance Abuse
HIV Infections
Interventions Drug: Aripiprazole
Drug: Placebo
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description Aripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve. 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.
Period Title: Overall Study
Started 45 45
Completed 35 40
Not Completed 10 5
Arm/Group Title Aripiprazole Placebo Total
Hide Arm/Group Description aripiprazole daily for 3 months placebo daily for 3 months Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
 100.0%
45
 100.0%
90
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
37.4  (12.3) 40  (8.9) 38.7  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
6
  13.3%
5
  11.1%
11
  12.2%
Male
39
  86.7%
40
  88.9%
79
  87.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 45 participants 90 participants
45 45 90
1.Primary Outcome
Title To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.
Hide Description 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.
Time Frame Final study visit at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description:
aripiprazole daily for 3 months
placebo daily for 3 months
Overall Number of Participants Analyzed 45 45
Measure Type: Number
Unit of Measure: perc of positive urines at final visit
44 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .41
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value .88
Confidence Interval 95%
.66 to 1.16
Estimation Comments [Not Specified]
2.Primary Outcome
Title 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.
Hide Description 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.)
Time Frame Adherence as determined by MEMS (throughout study, up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description:
aripiprazole daily for 3 months
placebo daily for 3 months
Overall Number of Participants Analyzed 45 45
Mean (Standard Deviation)
Unit of Measure: percent adherence from MEMS
46  (32) 39  (27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Total reported adverse events (throughout study, up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description:
aripiprazole daily for 3 months
placebo daily for 3 months
Overall Number of Participants Analyzed 45 45
Measure Type: Number
Unit of Measure: total reported adverse events
156 144
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >=0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description aripiprazole daily for 3 months placebo daily for 3 months
All-Cause Mortality
Aripiprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/45 (6.67%)   4/45 (8.89%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
metastatic cancer  0/45 (0.00%)  1/45 (2.22%) 
Renal and urinary disorders     
rhabdomyolysis  1/45 (2.22%)  0/45 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
pneumonia  1/45 (2.22%)  0/45 (0.00%) 
Skin and subcutaneous tissue disorders     
abscess  0/45 (0.00%)  2/45 (4.44%) 
cellulitis  1/45 (2.22%)  0/45 (0.00%) 
Vascular disorders     
subdural hematoma  0/45 (0.00%)  1/45 (2.22%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   35/45 (77.78%)   36/45 (80.00%) 
Gastrointestinal disorders     
Gastroenteritis  1/45 (2.22%)  4/45 (8.89%) 
Nausea  2/45 (4.44%)  3/45 (6.67%) 
General disorders     
Drowsiness  6/45 (13.33%)  0/45 (0.00%) 
Fatigue  8/45 (17.78%)  0/45 (0.00%) 
Hyperbilirubinemia  3/45 (6.67%)  4/45 (8.89%) 
Toothache  3/45 (6.67%)  4/45 (8.89%) 
Viral Syndrome  1/45 (2.22%)  3/45 (6.67%) 
Hypernatremia  4/45 (8.89%)  0/45 (0.00%) 
Hypocalcemia  3/45 (6.67%)  2/45 (4.44%) 
Increased Alanine Transaminase (ALT)  8/45 (17.78%)  7/45 (15.56%) 
Increased Aspartate Transaminase (AST)  6/45 (13.33%)  4/45 (8.89%) 
Sweats  0/45 (0.00%)  4/45 (8.89%) 
Infections and infestations     
Skin and soft tissue infection  3/45 (6.67%)  5/45 (11.11%) 
Nervous system disorders     
Akathisia  12/45 (26.67%)  2/45 (4.44%) 
Anxiety  0/45 (0.00%)  3/45 (6.67%) 
Headache  2/45 (4.44%)  3/45 (6.67%) 
Restlessness  4/45 (8.89%)  1/45 (2.22%) 
Sleep Disturbance  3/45 (6.67%)  2/45 (4.44%) 
Psychiatric disorders     
Depressed Mood  3/45 (6.67%)  1/45 (2.22%) 
Renal and urinary disorders     
Urinary Tract Infection (UTI)  0/45 (0.00%)  3/45 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection (URI)  6/45 (13.33%)  4/45 (8.89%) 
Skin and subcutaneous tissue disorders     
Abrasions  3/45 (6.67%)  1/45 (2.22%) 
Abscess  1/45 (2.22%)  4/45 (8.89%) 
Contusion  1/45 (2.22%)  4/45 (8.89%) 
Laceration  0/45 (0.00%)  3/45 (6.67%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Phillip O. Coffin, Director of Substance Use Research
Organization: San Francisco Department of Public Health
Phone: 415-437-6282
EMail: phillip.coffin@sfdph.org
Layout table for additonal information
Responsible Party: Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT00497055     History of Changes
Other Study ID Numbers: 1R01DA022190-01 ( U.S. NIH Grant/Contract )
1R01DA022190-01 ( U.S. NIH Grant/Contract )
1R01DA023387-01 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Submitted: July 5, 2007
First Posted: July 6, 2007
Results First Submitted: December 12, 2012
Results First Posted: March 24, 2014
Last Update Posted: March 24, 2014