Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 eight-week open-label trial to obtain preliminary data regarding the safety, tolerability, and potential utility of lisdexamfetamine for treatment of cocaine dependence and to determine an effective dosage range.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine; Lisdexamfetamine Dimesylate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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