Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT00292110
• Date of registration: 14/02/2006
• Primary sponsor: National Institute on Drug Abuse (NIDA)
• Public title: Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management
• Scientific title: Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management
• Date of first enrolment: February 2004
• Target sample size: 300
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00292110
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Kenzie Preston, Ph.D.
• Affiliation: National Institute on Drug Abuse (NIDA)

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cocaine-Related Disorders

Opiate-Related Disorders

Intervention(s)

Behavioral: Contingency Management

Behavioral: Contingency Management/Noncontingent Incentives

Drug: Methadone

Drug: Methadone dose

Primary Outcome(s)

Abstinence from cocaine and heroin [Time Frame: 16 weeks]

Secondary Outcome(s)

Blood lipid profile [Time Frame: 50 weeks]

Cortisol and prolactin levels [Time Frame: 50 weeks]

HIV Risk Behaviors [Time Frame: 50 weeks]

Methadone plasma and saliva concentration [Time Frame: 50 weeks]

Psychological and psychosocial outcome [Time Frame: 50 weeks]

QT interval [Time Frame: 24 weeks]

Quality of life [Time Frame: 50 weeks]

Substance Dependence [Time Frame: 50 weeks]

Time to relapse [Time Frame: 24 weeks]

Urine microalbuminuria [Time Frame: 24 weeks]

Secondary ID(s)

04-DA-N390

999904390

Source(s) of Monetary Support

Please refer to primary and secondary sponsors