Studying Amphetamine Withdrawal in Humans
Condition: Methamphetamine Dependence
Intervention: Dextroamphetamine; Placebo
Intervention description: 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.; 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.
Intervention MeSH terms: Dextroamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: methamphetamine withdrawal; mood; retention; sleep

Summary:

      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.
    

Eligibility 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