Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence

Methamphetamine Dependence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034201
• Other study ID #: 119273
• Secondary ID: R21DA034824-01A1
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2014
• Last updated: August 17, 2017
• Start date: February 2014
• Est. completion date: May 19, 2016

Study information

• Verified date: August 2017
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 19, 2016
• Est. primary completion date: May 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

Drug:
• Lisdexamfetamine

• Placebo

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants that relapse to methamphetamine use.		9 weeks