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Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034201
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Drug: Lisdexamfetamine Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2014
Actual Primary Completion Date : May 19, 2016
Actual Study Completion Date : May 19, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Active Comparator: Lisdexamfetamine
Lisdexamfetamine will be admistered at 140 mg orally daily through week 6 of the protocol.
Drug: Lisdexamfetamine
Placebo Comparator: Placebo
Placebo will be administered orally daily through week 6 of the protocol.
Drug: Placebo



Primary Outcome Measures :
  1. Percentage of participants that relapse to methamphetamine use. [ Time Frame: 9 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age (18-65 yrs).
  2. 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.
  3. Self-reported average METH use of at least 250 mg of methamphetamine per occasion at least once weekly during the preceding 3-month period.
  4. 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.
  5. 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.
  6. Normal blood pressure with SBP >89 and < 141, DBP >59 and < 91.

Exclusion Criteria:

  1. Current suicidality or psychosis
  2. Current cocaine dependence or opioid, alcohol, or sedative physical dependence
  3. 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
  4. History of schizophrenia or bipolar type I disorder
  5. Use of medications that would be expected to have major interaction with LDX including psychotropics
  6. Medical contraindication to receiving LDX
  7. Positive drug screen for cocaine, opiates, sedatives or PCP.
  8. History of Seizure disorder
  9. Documented hypersensitivity to sympathomimetic amines
  10. LFT >3xULN
  11. Pregnancy/nursing
  12. Current use or past 2 weeks use of MAOi
  13. History of Narrow-angle glaucoma

g.n. History of Hyperthyroidism


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034201


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
National Institute on Drug Abuse (NIDA)
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02034201    
Other Study ID Numbers: 119273
R21DA034824-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents