Real Time Assessment of Drug Craving, Use, and Abstinence During Outpatient: A Development and Feasibility Study
Condition: Cocaine Addiction; Opiate Addiction
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders; Behavior, Addictive
Study type: Observational

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.
    

Detailed description: 
      Background. We have already completed the original, major arm of this protocol (a
      natural-history study of craving and lapse). Still open for enrollment is the second minor
      arm (a within-subject trial of PDA-based treatment-task reminders). In the third arm there
      will be enhanced assessment of mood, stress, and geographical location to further study
      craving and lapse. All arms of the study have developed from either or both of two aspects of
      the original arm: (1) Our growing appreciation of the technical possibilities of electronic
      data collection in participants daily environments, and (2) our growing interest in having
      participants provide descriptive data about the day-to-day experience of addiction and
      recovery.

      The major completed arm of the protocol has provided a wealth of descriptive data on drug
      craving and lapse via Ecological Momentary Assessment (EMA), in which participants carry
      handheld data-collection devices (electronic diaries, EDs) on which they report, in real
      time, their activities and moods. Beyond data monitoring, EDs can be used to complement
      behavioral interventions. The data-collection devices can be additionally programmed to
      prompt completion of therapist-assigned homework exercises; by extending support outside the
      therapy session, clinical outcome may be improved. Furthermore, there is an evidenced
      association between completion of homework exercises and therapeutic outcome. Adapting
      existing homework assignments to make them more engaging may increase homework completion
      and, in turn, general compliance with therapy (Arm 2). The rationale for the third arm of the
      study is to broaden the perspective of the examination of the natural history of drug
      cravings and lapses by refining our assessments of geographical location and the stressors
      associated with it. In doing so, we intend to investigate determinants of addiction that are
      not reducible to individual-level traits but are instead reflective of broader socioeconomic
      problems manifested in differences among neighborhoods.

      Scientific goals. Arm 1) To investigate the relationships between putative triggers and drug
      craving and lapse; Arm 2) To investigate interactive effects of electronic-diary reminders,
      and simplified therapy-assigned homework tasks, on homework completion and therapeutic
      outcome; Arm 3) Using refinements in our assessment methods, to investigate the role of
      stress associated with geographical location in drug craving and use.

      Participant population. Arm 2: 35 cocaine-abusing opioid-dependent outpatients. Arm 3: 50
      cocaine-abusing opioid-dependent outpatients (separate from those in Arm 2). Target
      enrollment for both arms will include 40% women and 60% minorities (mostly African-American).

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      Experimental design and methods. After 3 weeks of stabilization on daily methadone,
      outpatients will undergo 25 weeks of EMA. 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). Target quit dates for heroin
      and cocaine will occur, respectively, on the first and third weeks of EMA. Two days after the
      cocaine quit date, all participants will begin 12 weeks of intensive voucher-based
      contingency management to reinforce abstinence from heroin and cocaine. Arm 2: During the
      same 12 weeks, a within-subjects manipulation will occur: participants will receive
      simplified versions of the current counselor-assigned homework tasks, and participants will
      receive a daily reminder via the PDA to complete their homework tasks (whether they are
      standard or simplified versions). The simplified homework tasks and reminders will be given
      during two separate, counterbalanced, three-week blocks. Arm 3: Starting at week 4 and
      continuing through week 18 participants will answer enhanced EMA questions regarding stress,
      mood, location, drug craving and use. Additionally, participants in Arm 3 will carry GPS
      units to record their locations during these 15 weeks. GPS location will be examined with
      their drug use, craving and self-reported mood. They will also complete retrospective stress
      questionnaires at week 3 and then at 4-week intervals throughout the completion of the study:
      week 7, 11, 15, 19, 23, and 27. After the 12-week homework (Arm 2) or enhanced EMA phase (Arm
      3) ends, participants will have the choice of transferring to a community clinic or
      undergoing an eight-week taper from methadone. For participants in Arm 2 who choose to detox
      at Archway, EMA may continue. However, for participants in Arm 3, no EMA or GPS data will be
      collected during the pre-detox or detox phase (weeks 19-28).

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      Benefits to participants and/or society. Direct benefits to participants include
      psychological and pharmacologic assistance for decreasing illicit drug use. The methadone
      administered during the study will decrease the participants intravenous opiate use. The
      contingency management and psychotherapy procedures may further reduce drug use and HIV risk
      behaviors. The decrease in HIV risk behaviors should result in lower incidence of HIV
      disease. Benefits to society include an increase in scientific understanding of the
      precipitants and process of craving, lapse, and relapse, and an improvement in our ability to
      assess the clinical effectiveness of relapse-prevention medications in future clinical
      trials.

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      Risks to participants. Participants on methadone may experience side effects of sedation,
      constipation, or mild euphoria. The risks of overmedication will be reduced by gradually
      increasing the dose of methadone over the first week. The methadone dose used in Arm 2 of
      this protocol, 100 mg, is within the limits allowed by the FDA guidelines and within the dose
      range used in methadone clinics in Baltimore. For Arm 3 of the protocol, there is no ceiling
      methadone dose. Methadone doses will be adjusted by the MRP as clinically indicated based on
      participant feedback, withdrawal signs/symptoms, reported cravings, and urine toxicology
      results. If a patient shows signs of intoxication, the MRP will reduce the methadone dose
      until evidence of intoxication has subsided. Methadone will be discontinued if a participant
      experiences severe side effects. Participants who are withdrawn from methadone will
      experience opiate withdrawal symptoms, but these symptoms will be minimized by the long detox
      period of 8 to 12 weeks. Other risks are the inconvenience of carrying and using the EDs, and
      possible embarrassment from providing urine samples under observation, and concern about the
      collection of GPS data.
    

Time perspective: Prospective
Keywords: Cocaine Dependence; Drug Relapse; Pharmacokinetics; EMA; Polydrug Abuse