Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

NCT01490216 | Terminated Phase 1 FDA Drug

• 1 other identifier: 3002-11961-00006857
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cocaine Dependence

Keywords

cocaine; lisdexamfetamine; vyvanse

Outcome Measures

Primary Outcomes (1)

• maximum total lisdexamfetamine dose achieved during the study period defined as the highest amount of medication per day maintained for a seven day period

  Study weeks 3-6

Study Arms (1)

lisdexamfetamine

OTHER

open label

Drug: lisdexamfetamine

Interventions

lisdexamfetamine DRUG

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

Also known as: vyvanse

lisdexamfetamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual -IV criteria for current cocaine dependence
• Used cocaine at least four days in the past month
• Individuals must be in good general health
• Individuals must be capable of giving informed consent and capable of complying with study procedures
• 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.

You may not qualify if:

• Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
• 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
• Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention
• Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)
• Individuals with current suicidal risk
• Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
• 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
• Individuals with a history of seizures, hyperthyroidism and/or glaucoma
• History of allergic reaction to study medication
• Women who are pregnant or nursing
• Currently being prescribed psychotropic medication by another physician (other than sleep medication)
• Individuals who are legally mandated (e.g., to avoid incarceration) to participate in substance abuse treatment program

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Marc E Mooney, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 12, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

US (1)