Clinical trial NCT01486810: Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Official title: Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cocaine Dependence
Keywords: cocaine
lisdexamfetamine
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-12-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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-fixed dosing schedule under open-label conditions. Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks, followed by a two week run-down period. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.

The primary outcome measures will be 1) the maximum total lisdexamfetamine dose achieved during the study period defined as the highest amount of medication per day maintained for a seven day period 2) lisdexamfetamine tolerability as measured by adverse effects reported on the Systematic Assessment for Treatment and Emergent Events (SAFTEE). Secondary outcome measures will be 1) cocaine use as recorded by the number of days of use on the Timeline Follow-Back method (Sobell \& Sobell, 1992) and confirmed by urine toxicology, 2) cocaine craving as measured by the Cocaine Craving Scale (CCS) and Cocaine Craving Questionnaire (CCQ) and 3) alternate measures of cocaine use, such as the dollar value of cocaine used per day, as measured by the Timeline Follow-Back method, and the proportion of urine toxicology samples negative for cocaine.

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

Primary outcomes:
measure: Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose.
timeFrame: during 1 week of study participation
measure: Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial.
timeFrame: during 8 weeks of trial or length of participation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: STARS
state: New York
Study officials:
affiliation: Columbia University
name: John Mariani, M.D.
role: PRINCIPAL_INVESTIGATOR
References: