Status:
COMPLETED
Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Opiate-Related Disorders
Cocaine-Related Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Background: \- The treatment of addiction often hinges on preventing relapse into drug-using behaviors, which occurs at high rates even after prolonged abstinence. Some methadone patients continue to...
Detailed Description
Scientific goals. The primary goal is to determine if simultaneous abstinence from heroin and cocaine can be elicited by combining two approaches: flexible methadone dosing and voucher-based CM. Secon...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- age between 18 and 65;
- physical dependence on opioids
- evidence of cocaine use, by urine screen and self-report
- able to attend methadone clinic 7 days/week
- EXCLUSION CRITERIA:
- History of schizophrenia or any other DSM-IV psychotic disorder
- History of bipolar disorder
- Current Major Depressive Disorder;
- Current physical dependence on alcohol or sedative-hypnotics, e.g. benzodiazepines
- Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires (Shipley Institute of Living scale-estimated full-scale IQ less than 80)
- Medical illness that in the view of the investigators would compromise participation in research
- Urologic conditions that would inhibit urine collection
- Previous bowel obstruction.
- Previous history of the following: major abdominal surgery, major gynecologic / pelvic surgery, inflammatory bowel disease (Crohn s or ulcerative colitis), Meckel s diverticulum, congenital atresia or stenosis, diverticulitis, radiation enteropathy or stricture, bowel neoplasm, endometriosis, inguinal-femoral-umbilical-ventral hernia, volvulus, or neurogenic megacolon, frequent bezoars.
- Recent use of medications known to cause severe constipation.
- History of previous severe respiratory depression or coma due to methadone use.
- Pregnancy.
- Personal history of a serious arrhythmia such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes; personal history of congenital heart disease or arrhythmia.
- Personal history of congenital long QT syndrome (LQT).
- Family history of a congenital long QT syndrome.
- Family history of Torsade de pointes.
- Family history of sudden cardiac death below the age of forty years.
- Evidence of clinically significant structural heart disease.
- Personal history of severe electrolyte disorders.
- Recent use of anti-arrhythmic agents.
- Poor venous access.
- Lab values outside the parameters set in Table II. These exclusion values are based upon the Medical Screening guideline used previously at the NIDA-IRP.
- CD4 less than 200 or evidence of severely compromised immune system / AIDS
- Women who are able to get pregnant must agree to use a medically effective form of contraception while in the study.
- Acceptable forms of contraception for this study include:
- Hormonal contraception (birth control pills, injected hormones, vaginal ring)
- Intrauterine device
- Barrier methods with spermicide (diaphragm with spermicide, condom with spermicide)
- Surgical sterilization (hysterectomy, tubal ligation, or vasectomy in a partner)
- Women who do not agree to use these medically effective forms of contraception while in the study will be excluded.
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2013
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00292110
Start Date
February 1 2004
End Date
August 9 2013
Last Update
December 17 2019
Active Locations (1)
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1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224