Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
Stopped early · Phase 1
Conditions studied: Cocaine Dependence
In brief
The purpose of this study is to evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and craving.
Key facts
- Study ID
- NCT01490216
- Run by
- University of Minnesota
- People needed
- 43
- Starts
- 2011-07-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2019-07-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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