Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence

NCT ID: NCT02034201

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-05-19

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.

Conditions

Methamphetamine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lisdexamfetamine

Lisdexamfetamine will be admistered at 140 mg orally daily through week 6 of the protocol.

Group Type: ACTIVE_COMPARATOR

Lisdexamfetamine

Intervention Type: DRUG

Placebo

Placebo will be administered orally daily through week 6 of the protocol.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Lisdexamfetamine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

R21DA034824-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

119273

Identifier Type: -

Identifier Source: org_study_id