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

NCT00292136 | Completed

• 2 other identifiers: 99990338503-DA-N385
• Study Type: observational
• Target: 230
• 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. 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.

Conditions

Cocaine Addiction; Opiate Addiction

Keywords

Cocaine Dependence; Drug Relapse; Pharmacokinetics; EMA; Polydrug Abuse

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;
• Evidence of physical dependence on opioids (self-report and physical exam);
• Evidence of cocaine and opiate use (self-report and urine screen).
• \<TAB\>

You may not qualify if:

• Schizophrenia or any other DSM-IV psychotic disorder; history of bipolar disorder; current Major Depressive Disorder;
• Current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by DSM-IV criteria);
• Cognitive impairment severe enough to preclude informed consent or valid self-report;
• Medical illness that in the view of the investigators would compromise participation in research;
• Urologic conditions that would inhibit urine collection;
• 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.

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 (1)

• Willner-Reid J, Whitaker D, Epstein DH, Phillips KA, Pulaski AR, Preston KL, Willner P. Cognitive-behavioural therapy for heroin and cocaine use: Ecological momentary assessment of homework simplification and compliance. Psychol Psychother. 2016 Sep;89(3):276-93. doi: 10.1111/papt.12080. Epub 2015 Nov 4.

  PMID: 26530031 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Kenzie Preston, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: August 15, 2003
• Study Completion: June 11, 2013
• Last Updated: April 5, 2018

Record last verified: 2013-06-11

Locations

US (1)