Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence

• Sponsor: University of Arkansas (Other)
• Overall Status: Completed
• CT.gov ID: NCT02034201
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 27.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: May 19, 2016
• Actual Study Completion Date: May 19, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of participants that relapse to methamphetamine use. [9 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

• University of Arkansas
• National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT02034201
• Other Study ID Numbers: 119273; R21DA034824-01A1
• First Posted: Jan 13, 2014
• Last Update Posted: Aug 22, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Lisdexamfetamine Dimesylate

Study Results

No Results Posted as of Aug 22, 2017