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Brief Intervention for Prescription Drug Misuse in General Hospital (MIMIK)

Primary Purpose

Substance-related Disorders

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Motivational Interviewing
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-related Disorders focused on measuring Prescription drug use disorder, Brief intervention, General hospital, Motivational Interviewing

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Prescription drug abuse
  • Prescription drug dependence
  • Regular prescription drug consumption (>60 times/last three months)

Exclusion Criteria:

  • Current treatment for substance abuse problems
  • Terminal illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    C

    MI

    Arm Description

    Control group receiving a booklet on health behavior

    Counselling based on Motivational Interviewing plus individualized feedback

    Outcomes

    Primary Outcome Measures

    Discontinuation of consumption of prescription drugs
    Reduction of consumption of prescription drugs
    Utilization of formal help

    Secondary Outcome Measures

    Readiness to change consumption of prescription drugs

    Full Information

    First Posted
    August 9, 2007
    Last Updated
    April 1, 2014
    Sponsor
    University of Luebeck
    Collaborators
    Federal Ministry of Health, Germany
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00514839
    Brief Title
    Brief Intervention for Prescription Drug Misuse in General Hospital
    Acronym
    MIMIK
    Official Title
    Brief Intervention for Regular Prescription Drug Use and Prescription Drug Use Disorders in General Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    February 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Luebeck
    Collaborators
    Federal Ministry of Health, Germany

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In a randomized controlled trial, patients recruited in a general hospital and fulfilling criteria for regular consumption (more than 60 days within the last three months), dependence or abuse of prescription drugs will be randomly allocated to two conditions:(1) Intervention group consisting of two counselling sessions based on Motivational Interviewing plus a personalized feedback, (2) Control group receiving a booklet on health behavior. Outcome assessment will be conducted after 12 months. The hypothesis is that counseling leads to greater reduction in consumption of prescription drugs (including discontinuation) and elevated readiness to change at follow-up.
    Detailed Description
    Background: Dependence on prescription drugs (DPD) is highly prevalent, whereby rate of substance specific treatment is low. A pilot study revealed elevated prevalence rates in general hospital patients compared to the general population and a positive attitude of patients suffering from DPD towards counseling. Brief intervention delivered in general hospital might be useful to promote discontinuation of prescription drug use and utilization of formal help. Objectives: To test the efficacy of a brief intervention based on Motivational Interviewing in proactively recruited general hospital patients randomly allocated to an intervention or a control group. Methods: Patients aged 18 to 69 years are proactively recruited in surgical and internal wards of two general hospitals in the northern German city of Lübeck. Patients with regular use of prescription drugs in the last three months and/or prescription drug dependence or -abuse are randomly assigned to two conditions: (1) an intervention group with two counseling sessions based on Motivational Interviewing plus one individualized feedback based on the Transtheoretical Model of behavior change (TTM) or (2) as usual care. Outcome measures are reduction or discontinuation of prescription drug use and utilization of formal help. The efficacy of the intervention will be examined within a 3 and a 12 month follow up. Expected impact: Findings are expected to provide evidence for brief interventions for prescription drug misuse to be used in primary care. This would be the first international results confirming such an approach in the field of prescription drug misuse. If a brief interventions would be effective, this could enhance secondary prevention for this under served population. Therefore, data are of great public health interest.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance-related Disorders
    Keywords
    Prescription drug use disorder, Brief intervention, General hospital, Motivational Interviewing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    126 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    C
    Arm Type
    No Intervention
    Arm Description
    Control group receiving a booklet on health behavior
    Arm Title
    MI
    Arm Type
    Experimental
    Arm Description
    Counselling based on Motivational Interviewing plus individualized feedback
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational Interviewing
    Intervention Description
    Two sessions of Motivational Interviewing (after baseline assessment and 4 weeks later) plus one individualized feedback based on the Transtheoretical Model of Behavior Change (8 weeks after baseline assessment)
    Primary Outcome Measure Information:
    Title
    Discontinuation of consumption of prescription drugs
    Time Frame
    one year
    Title
    Reduction of consumption of prescription drugs
    Time Frame
    one year
    Title
    Utilization of formal help
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Readiness to change consumption of prescription drugs
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Prescription drug abuse Prescription drug dependence Regular prescription drug consumption (>60 times/last three months) Exclusion Criteria: Current treatment for substance abuse problems Terminal illness
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hans-Juergen Rumpf, Ph.D.
    Organizational Affiliation
    University of Luebeck
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19133895
    Citation
    Zahradnik A, Otto C, Crackau B, Lohrmann I, Bischof G, John U, Rumpf HJ. Randomized controlled trial of a brief intervention for problematic prescription drug use in non-treatment-seeking patients. Addiction. 2009 Jan;104(1):109-17. doi: 10.1111/j.1360-0443.2008.02421.x.
    Results Reference
    derived

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    Brief Intervention for Prescription Drug Misuse in General Hospital

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