Status:
COMPLETED
A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse
Lead Sponsor:
Indivior Inc.
Conditions:
Opioid Dependence
Opioid Related Disorders
Eligibility:
All Genders
21-50 years
Phase:
PHASE2
Brief Summary
This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male and female subjects with an American Psychiatric Association Diagnostic and Statistical Manual DSM-IV-TR diag...
Detailed Description
There will be a 28-day screening period with eligible subjects remaining resident in the clinic from the evening before Day -1 up and until the morning of Day 9. On the morning of Day 1, a 50 mg intra...
Eligibility Criteria
Inclusion
- Male and female volunteers aged 21-50 years, inclusive
- Body mass index (BMI)18-32 kg/m\^2 and weight of at least 50 kg
- Not currently seeking treatment for substance abuse or substance dependence
- Subject is healthy, in the opinion of the Principal Investigator other than cocaine abuse; as determined by the absence of clinically significant medical/psychiatric history or findings, particularly cardiovascular or central nervous system (CNS) disease, physical examination, normal renal function, ECG findings, vital signs, and laboratory results at screening
- Males agree to refrain from sperm donations for the entire duration of the study, and for at least 90 days after the last dose of study drug
- Has experience using cocaine by the smoked or IV route at least 6 times in past 12 months and a positive urine drug screen for cocaine prior to study intake (Day -2). Has experience using cocaine by the smoked or IV route in the past 3 months and a positive urine drug screen for cocaine during screening prior to study check-in at the clinic
- Be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, prior to the initiation of any protocol-specific procedures
- Meet DSM-IV-TR criteria for current cocaine abuse
- Be able to comply with protocol requirements, rules, and regulations of the study site, and be likely to complete all the study procedures in the opinion of the Principal Investigator
Exclusion
- Current or past history of seizure disorder, including alcohol- and/or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder. Have any previous clinically significant reaction to cocaine, including loss of consciousness or seizure
- Current alcohol dependence or current drug dependence according to DSM-IV-TR criteria (excluding nicotine and caffeine)
- Clinically significant history of cardiac disease, including cardiovascular and conduction abnormalities or ECG evidence of cardiac abnormalities
- QTcF greater than or equal to 450 for male subjects and 470 for female subjects as measured through a 12-lead ECG
- History of liver disease or current elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 3x the upper limit of normal
- Be on probation or parole, and/or have current or pending legal charges with the potential for incarceration that could interfere with the study scheduling
- Women with a positive pregnancy test at screening; or women who are pregnant or lactating or who are seeking to become pregnant
- Women of childbearing potential (who are sexually active with a male) who fail to use medically acceptable contraception methods (e.g., an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, a double barrier method, or barrier plus spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilization, e.g., bilateral tubal ligation, bilateral ovariectomy (oophorectomy). Females that are post-menopausal will be confirmed as such by the follicle stimulating hormone (FSH) test at initial screening
- Males who do not agree to use barrier contraception and spermicide when engaging in sexual activity with a female of child-bearing potential while on study medication, and for at least 28 days after the last dose of study medication
- History of clinically significant severe allergic or anaphylactic reactions
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01846481
Start Date
April 1 2013
End Date
June 1 2013
Last Update
September 23 2016
Active Locations (1)
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1
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212