Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

NCT ID: NCT01490216

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-01-31

Brief Summary

The purpose of this study is to evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and craving.

Detailed Description

Evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and craving as determined by self-report and cocaine-positive urine samples.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

lisdexamfetamine

open label

Group Type: OTHER

lisdexamfetamine

Intervention Type: DRUG

20mg q.d. to 70mg b.i.d

Interventions

lisdexamfetamine

20mg q.d. to 70mg b.i.d

Intervention Type: DRUG

Other Intervention Names

vyvanse

Eligibility Criteria

Inclusion Criteria

1. Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual -IV criteria for current cocaine dependence

2. Used cocaine at least four days in the past month

3. Individuals must be in good general health

4. Individuals must be capable of giving informed consent and capable of complying with study procedures

5. Women of child-bearing age must agree to use a method of contraception with proven efficacy, consisting of one of the following: 1) Any form of hormonal contraception; 2) Intra-uterine device; 3) Sterilization; 4) Double-barrier contraception which is a combination of two of the following: condoms, spermicide, diaphragm. Pregnancy tests will be performed monthly and if a woman becomes pregnant, the study medication will be discontinued.

Exclusion Criteria

1. Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse

2. Individuals with any other current Axis I psychiatric disorder as defined by DSM-IV-TR that in the investigator's judgment are unstable, or would be disrupted by study medication, or are likely to require pharmacotherapy during the study period

3. Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention

4. Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)

5. Individuals with current suicidal risk

6. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms

7. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP > 140, diastolic blood pressure > 90, or heart rate > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases (< 3x upper limit of normal are acceptable), or uncontrolled diabetes

8. Individuals with a history of seizures, hyperthyroidism and/or glaucoma

9. History of allergic reaction to study medication

10. Women who are pregnant or nursing

11. Currently being prescribed psychotropic medication by another physician (other than sleep medication)

12. Individuals who are legally mandated (e.g., to avoid incarceration) to participate in substance abuse treatment program

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

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc E Mooney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

3002-11961-00006857

Identifier Type: -

Identifier Source: org_study_id