Phase 2
Completed N=17
Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Cocaine Dependence
Source: ClinicalTrials.gov NCT01486810 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose. — 12 Participants
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.
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 | — |
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. Informational only — not medical advice.