- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02034201
Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence
August 17, 2017 updated by: University of Arkansas
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lisdexamfetamine
Lisdexamfetamine will be admistered at 140 mg orally daily through week 6 of the protocol.
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Placebo Comparator: Placebo
Placebo will be administered orally daily through week 6 of the protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participants that relapse to methamphetamine use.
Time Frame: 9 weeks
|
9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
May 19, 2016
Study Completion (Actual)
May 19, 2016
Study Registration Dates
First Submitted
January 9, 2014
First Submitted That Met QC Criteria
January 9, 2014
First Posted (Estimate)
January 13, 2014
Study Record Updates
Last Update Posted (Actual)
August 22, 2017
Last Update Submitted That Met QC Criteria
August 17, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 119273
- R21DA034824-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Methamphetamine Dependence
-
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