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Studying Amphetamine Withdrawal in Humans

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ClinicalTrials.gov Identifier: NCT01215929
Recruitment Status : Completed
First Posted : October 7, 2010
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Methamphetamine Dependence
Interventions Drug: Dextroamphetamine
Drug: Placebo
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dextroamphetamine Placebo
Hide Arm/Group Description Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks. Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
Period Title: Overall Study
Started 18 17
Completed 12 12
Not Completed 6 5
Arm/Group Title Dextroamphetamine Placebo Total
Hide Arm/Group Description Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks. Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 18 17 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 17 participants 35 participants
41.00  (9.76) 33.67  (6.34) 35.36  (8.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Female
9
  50.0%
9
  52.9%
18
  51.4%
Male
9
  50.0%
8
  47.1%
17
  48.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
18
 100.0%
17
 100.0%
35
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 17 participants 35 participants
18 17 35
1.Primary Outcome
Title Measure of Methamphetamine Withdrawal
Hide Description Total score on the Methamphetamine Withdrawal Assessment scale (MAWA) based on DSMIV criteria for amphetamine withdrawal. This questionnaire is comprised of 13 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score indicating no methamphetamine withdrawal symptoms is 0 and the maximum score is 4 indicating that a patient has the most severe withdrawal symptom related to that question. The subscales are the 13 questions and the total score is the sum of all the scores for the 13 items on the scale. The range minium and better outcome is a lower score. The range is from 0-52. The worse outcome is reflected in a higher score.
Time Frame at the end of week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dextroamphetamine Placebo
Hide Arm/Group Description:
Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
Placebo: Thirty-five treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
Overall Number of Participants Analyzed 12 12
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.7283  (3.37) 10.056  (3.45)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dextroamphetamine Placebo
Hide Arm/Group Description Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks. Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
All-Cause Mortality
Dextroamphetamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dextroamphetamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dextroamphetamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   8/18 (44.44%)   9/17 (52.94%) 
Cardiac disorders     
Tachycardia *  3/18 (16.67%)  6/17 (35.29%) 
Nervous system disorders     
Headache *  2/18 (11.11%)  3/17 (17.65%) 
Psychiatric disorders     
Insomnia *  3/18 (16.67%)  2/17 (11.76%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michael J Mancino MD
Organization: UAMS
Phone: 501-526-8440
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01215929     History of Changes
Other Study ID Numbers: 110743
First Submitted: October 1, 2010
First Posted: October 7, 2010
Results First Submitted: June 12, 2014
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014