Real Time Assessment of Drug Craving, Use, and Abstinence During Outpatient: A Development and Feasibility Study

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00292136
First received: February 14, 2006
Last updated: February 19, 2014
Last verified: June 2013
  Purpose

Background:

  • The treatment of addiction often hinges on preventing relapse into drug-using behaviors, which occurs at high rates even after prolonged abstinence. Research has shown that constant reporting through personal data-collection devices, such as electronic diaries, can help prevent relapse and reinforce abstinence. This constant reporting is known as Ecological Momentary Assessment (EMA).
  • The researchers here at NIDA have already completed two major arms of the study, focusing on patterns of craving and drug use during methadone maintenance, and on whether electronic diaries could help remind outpatients to complete treatment tasks. An ongoing arm of the study is examining connections among drug craving/use, stress, and geographical location.

Objective:

- To investigate the role of stress associated with geographical location in drug craving and use.

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 28 weeks. After the initial screening, participants will receive daily methadone and weekly drug counseling sessions that will continue throughout the study.
  • After 3 weeks of methadone treatment, participants will have 15 weeks of EMA in which they will record both event-triggered cravings and daily responses (3 per day). EMA will consist of event-triggered recordings (initiated by participants whenever they use heroin or cocaine, or whenever they feel an urge to do so) and random-signal-triggered recordings (3 per day). During EMA, participants will begin a voucher-based program to encourage abstinence from heroin and cocaine.
  • Participants will also carry global positioning system (GPS) units to record their locations during these 15 weeks, and will complete questionnaires about stress levels at specific intervals during the study.
  • At the end of the study, participants will have the choice of transferring to a community clinic or undergoing an 8-week taper from methadone.

Condition
Cocaine Addiction
Opiate Addiction

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Real Time Assessment of Drug Craving, Use, and Abstinence During Outpatient: A Development and Feasibility Study

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 250
Study Start Date: August 2003
Estimated Study Completion Date: June 2013
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Age between 18 and 65;
    2. Evidence of physical dependence on opioids (self-report and physical exam);
    3. Evidence of cocaine and opiate use (self-report and urine screen).

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EXCLUSION CRITERIA:

  1. Schizophrenia or any other DSM-IV psychotic disorder; history of bipolar disorder; current Major Depressive Disorder;
  2. Current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by DSM-IV criteria);
  3. Cognitive impairment severe enough to preclude informed consent or valid self-report;
  4. Medical illness that in the view of the investigators would compromise participation in research;
  5. Urologic conditions that would inhibit urine collection;
  6. In arm 2 only: current or recent maintenance on a methadone dose substantially higher than the arm 2 ceiling dose of 100 mg/day; the MRP will evaluate this case by case.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292136

Locations
United States, Maryland
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Investigators
Principal Investigator: Kenzie Preston, Ph.D. National Institute on Drug Abuse (NIDA)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00292136     History of Changes
Other Study ID Numbers: 999903385, 03-DA-N385
Study First Received: February 14, 2006
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cocaine Dependence
Drug Relapse
Pharmacokinetics
EMA
Polydrug Abuse

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior

ClinicalTrials.gov processed this record on October 16, 2014