Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence

Methamphetamine dependence is a serious public health problem, with methamphetamine abusers being at risk for significant morbidity and mortality, including HIV. To date, no medication or psychotherapeutic strategy has shown robust, long-term efficacy in treating this disorder. This clinical trial will examine whether lisdexamfetamine shows promise in alleviating withdrawal symptoms and preventing relapse relative to placebo in recently-abstinent methamphetamine dependent individuals. Findings of this study will not only shed light on whether lisdexamfetamine may improve upon treatment for this disorder but also inform future medication development strategies for improving treatment for drug dependence disorders. Discovering efficacious limited risk interventions that show more robust, longer-term outcomes would be beneficial both to the individual and society.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Methamphetamine Dependence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age (18-65 yrs).
Participants must fulfill DSM-IV criteria for Methamphetamine dependence These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on clinical assessments and the patient will also need to meet criteria for methamphetamine dependence based on administration of the SCID.
Self-reported average METH use of at least 250 mg of methamphetamine per occasion at least once weekly during the preceding 3-month period.
A positive urine toxicology screen for methamphetamine. Participants must submit a urine sample negative for drugs of abuse (opiates, benzodiazepines, cocaine and PCP) other than methamphetamine or marijuana during the week prior to starting the study.
Women of child-bearing potential will be included provided they 1) have a negative pregnancy test, 2) agree to adequate contraception (tubal ligation, hysterectomy, barrier contraceptive method or oral contraceptive method) to prevent pregnancy during the study and 3) are not nursing.
Normal blood pressure with SBP >89 and < 141, DBP >59 and < 91.

Exclusion criteria

Current suicidality or psychosis
Current cocaine dependence or opioid, alcohol, or sedative physical dependence
Major hepatic or cardiovascular disorder (including history of myocardial infarction, cardiovascular disease, or history of or currently clinically significant ECG abnormality) or unstable medical condition that contraindicates study participation
History of schizophrenia or bipolar type I disorder
Use of medications that would be expected to have major interaction with LDX including psychotropics
Medical contraindication to receiving LDX
Positive drug screen for cocaine, opiates, sedatives or PCP.
History of Seizure disorder
Documented hypersensitivity to sympathomimetic amines
LFT >3xULN
Pregnancy/nursing
Current use or past 2 weeks use of MAOi
History of Narrow-angle glaucoma

g.n. History of Hyperthyroidism

Treatment and study plan

Lisdexamfetamine

Drug

Placebo

Drug

Primary outcomes

Percentage of participants that relapse to methamphetamine use.

Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jan 13, 2014
Registry last updated: Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed