Phase 2
N=17
Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01486810 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose. — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lisdexamfetamine (Drug); medication management (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose. |
12 | — |
| PRIMARY Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial. |
118.1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01486810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.