Status:
COMPLETED
Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
The proposed protocol is an open-label pilot study of the treatment of cocaine dependence using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12 patients in an e...
Detailed Description
In an eight-week open label outpatient pilot trial, we will evaluate the safety, tolerability, and potential utility of LDX in the treatment of cocaine dependence. Patients will receive a flexible-fix...
Eligibility Criteria
Inclusion
- Individuals must be treatment seeking
- Men and women between the ages of 18-60 who meet DSM-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.
Exclusion
- Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, any psychotic disorder other than transient psychosis due to drug abuse, or current major depressive disorder
- 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, DBP\> 90, or HR \> 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases \< 1.5x upper limit of normal are acceptable), or uncontrolled diabetes
- Individuals with a history of seizures, hyperthyroidism and/or glaucoma
- Individuals with a family history of sudden cardiac death
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01486810
Start Date
December 1 2011
End Date
December 1 2013
Last Update
April 24 2019
Active Locations (1)
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1
STARS
New York, New York, United States, 10032