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
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
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
NCT ID
NCT00514839
First Posted
August 9, 2007
Last Updated
April 1, 2014
Sponsor
University of Luebeck
Collaborators
Federal Ministry of Health, Germany
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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