Studying Amphetamine Withdrawal in Humans



Status:Archived
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2009

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Amphetamine Withdrawal Paradigm in Humans


Methamphetamine use is very common in the US and is associated with serious medical and
psychiatric problems. There has also been a significant increase in the number of patients
entering treatment for methamphetamine dependence, however, no pharmacologic treatment has
been identified as effective in treating methamphetamine addiction. Given that withdrawal
from methamphetamine is thought to contribute to relapse to methamphetamine use during early
treatment, it is important to examine potential pharmacologic agents for alleviating
withdrawal. Thus, this study is designed to study methamphetamine withdrawal in humans. To
this end, 30 methamphetamine dependent participants (ages 18-65 years) will be entered into
a 4-week residential study. Urine samples will be obtained at baseline to ensure recent
methamphetamine use. Intake assessments will include cognitive testing, standardized
assessment of depression and anxiety, profile of mood states, methamphetamine selective
severity assessment, methamphetamine withdrawal assessment, sleep quality and quantity, a
pre-attentional measure and attentional measure. Upon admission to the residential
facility, all study participants will be started on (20-30mg) long acting
amphetamine/d-amphetamine and stabilized over the first 5 days. After stabilization
participants will be randomized based on sex, amphetamine withdrawal questionnaire score,
and methamphetamine selective severity assessment score to either continued treatment with
amphetamine/d-amphetamine or placebo for 2 weeks. All subjects will then be placed on
placebo for the last 7 days. The investigators hypothesis is that stopping amphetamine
administration in methamphetamine dependent individuals will negatively impact mood, sleep
and cognitive function in a time-limited fashion that may differ depending upon the measure
and that attentional, but not pre-attentional, measures will be adversely affected in those
receiving placebo compared to those maintained on amphetamine.



We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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from
Little Rock, AR
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