Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management

• Status: Completed
• Trial end date: 2013-08-09
• Target enrollment: 0
• Participant gender: All

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 abuse cocaine and heroin during treatment, even with extensive psychosocial services. More research is needed to look at the results from earlier studies of continued drug use during methadone treatment, focusing on the results of fixed vs. flexible doses of methadone to reduce the likelihood of continued drug use and the role of monetary vouchers as an incentive to continue abstinence from illicit substances.

Objectives:

• To determine if the combination of flexible methadone dosing and voucher-based contingency management can improve rates of abstinence from heroin and cocaine.

Eligibility:

• Individuals between 18 and 65 years of age or older who are dependent on opioids (cocaine and/or heroin).

Design:

• The study will last 40 weeks. After the initial screening, participants will receive daily methadone and weekly drug counseling sessions that will continue throughout the study.

• After 6 weeks of methadone treatment, participants who continue to use heroin and cocaine will be randomized to one of four groups for 16 weeks of study. Each group will receive a flexible or fixed dose of methadone, and one of two contingency management conditions.

• Flexible-dose participants will receive individualized dose increases, based on drug use and withdrawal. Fixed-dose participants will be set at a specific dose of methadone that will not be changed.

• The two contingency management conditions will be monetary vouchers given for regular cocaine-negative urine samples, or vouchers independent of urine cocaine screen results.

• After the study phase, participants will have 10 weeks of standard individual counseling and stable doses of methadone. Urine samples will continue to be collected, but no vouchers will be given.

• At the end of the study, participants will have the choice of transferring to a community clinic or undergoing a 10-week taper from methadone.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine; Heroin; Methadone

Criteria

• INCLUSION CRITERIA:

1. age between 18 and 65;

2. physical dependence on opioids

3. evidence of cocaine use, by urine screen and self-report

4. able to attend methadone clinic 7 days/week

EXCLUSION CRITERIA:

1. History of schizophrenia or any other DSM-IV psychotic disorder

2. History of bipolar disorder

3. Current Major Depressive Disorder;

4. Current physical dependence on alcohol or sedative-hypnotics, e.g. benzodiazepines

5. 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)

6. Medical illness that in the view of the investigators would compromise participation in research

7. Urologic conditions that would inhibit urine collection

8. Previous bowel obstruction.

9. 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.

10. Recent use of medications known to cause severe constipation.

11. History of previous severe respiratory depression or coma due to methadone use.

12. Pregnancy.

13. Personal history of a serious arrhythmia such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes; personal history of congenital heart disease or arrhythmia.

14. Personal history of congenital long QT syndrome (LQT).

15. Family history of a congenital long QT syndrome.

16. Family history of Torsade de pointes.

17. Family history of sudden cardiac death below the age of forty years.

18. Evidence of clinically significant structural heart disease.

19. Personal history of severe electrolyte disorders.

20. Recent use of anti-arrhythmic agents.

21. Poor venous access.

22. 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.

23. CD4 less than 200 or evidence of severely compromised immune system / AIDS

24. 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:

1. Hormonal contraception (birth control pills, injected hormones, vaginal ring)

2. Intrauterine device

3. Barrier methods with spermicide (diaphragm with spermicide, condom with spermicide)

4. 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.