Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management

NCT00292110 | Completed Phase 1

• 2 other identifiers: 99990439004-DA-N390
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Opiate-Related Disorders; Cocaine-Related Disorders

Keywords

HIV; Opiate Substitution; Pharmacokinetics; ECG; Polydrug Abuse

Outcome Measures

Primary Outcomes (1)

• Abstinence from cocaine and heroin

  16 weeks

Secondary Outcomes (10)

• Time to relapse

  24 weeks

• Psychological and psychosocial outcome

  50 weeks

• HIV Risk Behaviors

  50 weeks

• QT interval

  24 weeks

• Urine microalbuminuria

  24 weeks

Study Arms (4)

Arm Four

ACTIVE COMPARATOR

Drug: Methadone; Behavioral: Contingency Management/Noncontingent Incentives

Arm One

EXPERIMENTAL

Behavioral: Contingency Management; Drug: Methadone dose

Arm Three

ACTIVE COMPARATOR

Drug: Methadone dose

ArmTwo

ACTIVE COMPARATOR

Drug: Methadone; Behavioral: Contingency Management; Behavioral: Contingency Management/Noncontingent Incentives

Interventions

Methadone DRUG

100 mg/day orally

Arm Four; ArmTwo

Contingency Management BEHAVIORAL

Incentives given for cocaine abstinence

Arm One; ArmTwo

Methadone dose DRUG

flexible methadone dosing to 190 mg/day daily orally

Arm One; Arm Three

Contingency Management/Noncontingent Incentives BEHAVIORAL

Incentives given independent of drug use

Arm Four; ArmTwo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• Ball JC, Lange WR, Myers CP, Friedman SR. Reducing the risk of AIDS through methadone maintenance treatment. J Health Soc Behav. 1988 Sep;29(3):214-26. No abstract available.

  PMID: 3241064 BACKGROUND

• Barthwell A, Senay E, Marks R, White R. Patients successfully maintained with methadone escaped human immunodeficiency virus infection. Arch Gen Psychiatry. 1989 Oct;46(10):957-8. doi: 10.1001/archpsyc.1989.01810100099020. No abstract available.

  PMID: 2802930 BACKGROUND

• Belding MA, McLellan AT, Zanis DA, Incmikoski R. Characterizing "nonresponsive" methadone patients. J Subst Abuse Treat. 1998 Nov-Dec;15(6):485-92. doi: 10.1016/s0740-5472(97)00292-4.

  PMID: 9845861 BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Methadone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Kenzie Preston, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: February 1, 2004
• Primary Completion: August 9, 2013
• Study Completion: August 9, 2013
• Last Updated: December 17, 2019

Record last verified: 2013-08-09

Locations

US (1)