Studying Amphetamine Withdrawal in Humans

NCT01215929 | Completed Phase 2 Results DMC

• 1 other identifier: 110743
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Methamphetamine Dependence

Keywords

methamphetamine withdrawal; mood; retention; sleep

Outcome Measures

Primary Outcomes (1)

• Measure of Methamphetamine Withdrawal

  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.

  at the end of week 4

Study Arms (2)

Dextroamphetamine

ACTIVE COMPARATOR

Drug: Dextroamphetamine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dextroamphetamine DRUG

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.

Dextroamphetamine

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical SCiences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Interventions

Dextroamphetamine

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Michael J Mancino MD
• Organization: UAMS

mjmancino@uams.edu

501-526-8440

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2014
• Last Updated: August 4, 2014
• Results First Posted: August 4, 2014

Record last verified: 2014-07

Locations

US (1)