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Studying Amphetamine Withdrawal in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01215929
First received: October 1, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose
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.

Condition Intervention Phase
Methamphetamine Dependence Drug: Dextroamphetamine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amphetamine Withdrawal Paradigm in Humans

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Measure of Methamphetamine Withdrawal [ Time Frame: at the end of week 4 ]
    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.


Enrollment: 35
Study Start Date: October 2009
Study Completion Date: May 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dextroamphetamine Drug: Dextroamphetamine
Thirty treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility and be inducted onto d-amphetamine during week 1 of the study. 15 Participants then will 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 Comparator: Placebo Drug: Placebo
Thirty 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. 15 Participants then will be 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 week.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 21-65 years old
  • not currently enrolled in a treatment program
  • history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
  • self-reported Methamphetamine use on at least 15 of the past 30 days
  • use of at least one half gram of methamphetamine per week during the month prior to study entry
  • women of childbearing age must have a negative pregnancy test to enroll in this study

Exclusion Criteria:

  • current diagnosis of alcohol, opiate, or sedative physical dependence
  • ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
  • history of schizophrenia, or bipolar type I disorder
  • present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with d-amphetamine
  • medical contraindication to receiving study medications (e.g., previous adverse reaction to d-amphetamine)
  • chronic pain condition (due to impact on neurophysiological responses
  • current suicidality or psychosis
  • liver function tests (i.e., liver enzymes) greater than three times normal levels
  • pregnancy or breastfeeding
  • children 18-20 will be excluded because the P50 potential is not fully developed in children and adolescents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215929

Locations
United States, Arkansas
University of Arkansas for Medical SCiences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
  More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01215929     History of Changes
Other Study ID Numbers: 110743
Study First Received: October 1, 2010
Results First Received: June 12, 2014
Last Updated: July 14, 2014

Keywords provided by University of Arkansas:
methamphetamine withdrawal
mood
retention
sleep

Additional relevant MeSH terms:
Methamphetamine
Amphetamine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 22, 2017