Cocaine Dependence
Conditions
Keywords
cocaine, crack cocaine, cocaine-related disorders, substance-related disorders, alpha4beta2 nicotinic acetylcholine receptor
Brief summary
The purpose of this study is to determine whether varenicline (Chantix), is effective for the treatment of cocaine dependence.
Detailed description
The purpose of study is to determine if Varenicline (Chantix™) promotes cocaine abstinence in cocaine dependent individuals. Varenicline (Chantix™) (2.0 mg/day) or placebo will be administered in a 9-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence.
Interventions
DRUGvarenicline
1.0 mg BID for 8 weeks
DRUGplacebo
placebo BID for 8 weeks
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males and females, 18 to 65 years old. * Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID). * Live within a commutable distance of the Treatment Research Center (TRC) at the Penn/VA Center for Studies of Addiction, University of Pennsylvania. We define this to be a distance within the service area of Septa, within an hour drive, or a distance that both the patient and Principal Investigator (PI) find acceptable. * Understands and signs the informed consent.
Exclusion criteria
* Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine or nicotine dependence, as determined by the SCID. * Concomitant treatment with psychotropic medications. * Current or prior gambling problems. This will be assessed by the patient's self-report. * Patients mandated to treatment based upon a legal decision or as a condition of employment. This will be assessed by the patient's self-report. * Current severe psychiatric symptoms, e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring antidepressant therapy in the opinion of the Principal Investigator (PI) * Use of any investigational medication within the past 30 days. * History of significant heart disease (an arrhythmia which required medication, Wolff-Parkinson -White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure). * History of chest pain associated with cocaine use that has prompted a visit to a physician. * Current use of naltrexone, disulfiram, modafinil, stimulants, reserpine, verapamil, theophylline, trimethoprim, cimetidine, haloperidol, benzodiazepines or anticonvulsants. * Known hypersensitivity to varenicline. * Patients with known AIDS or other serious illnesses that may require hospitalization during the study. * Female subjects who are pregnant or lactating, or female subjects of child-bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include: * barrier (diaphragm or condom) with spermicide * intrauterine progesterone contraceptive system * levonorgestrel implant * medroxyprogesterone acetate contraceptive injection * oral contraceptives. * tubal ligation. * Patients with impaired renal function as indicated by corrected creatinine clearance below 80 ml/min/70 kg as determined by the modified Cockcroft equation (CDC, 1986). * Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator. EKG 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests \[LFTs\] \<5 x ULN are acceptable).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine. | 8 weeks | Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment. |
Countries
United States
Participant flow
Recruitment details
Thirty-seven treatment-seeking participants from the greater metropolitan Philadelphia area were randomized to participate in this trial.
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Varenicline (Chantix) | 18 |
| Placebo Placebo | 19 |
| Total | 37 |
Baseline characteristics
| Characteristic | Varenicline | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 19 Participants | 37 Participants |
| Region of Enrollment United States | 18 participants | 19 participants | 37 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 17 | 17 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.
Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine. | 2 participants |
| Placebo | Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine. | 1 participants |