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

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ClinicalTrials.gov Identifier: NCT00514839
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : April 2, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Substance-related Disorders Behavioral: Motivational Interviewing Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Intervention for Regular Prescription Drug Use and Prescription Drug Use Disorders in General Hospital
Study Start Date : November 2005
Primary Completion Date : August 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: C
Control group receiving a booklet on health behavior
Experimental: MI
Counselling based on Motivational Interviewing plus individualized feedback
Behavioral: Motivational Interviewing
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)


Outcome Measures

Primary Outcome Measures :
  1. Discontinuation of consumption of prescription drugs [ Time Frame: one year ]
  2. Reduction of consumption of prescription drugs [ Time Frame: one year ]
  3. Utilization of formal help [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Readiness to change consumption of prescription drugs [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514839


Sponsors and Collaborators
University of Luebeck
Federal Ministry of Health, Germany
Investigators
Principal Investigator: Hans-Juergen Rumpf, Ph.D. University of Luebeck
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hans-Jürgen Rumpf, PD Dr. Hans-Jürgen Rumpf, University of Luebeck
ClinicalTrials.gov Identifier: NCT00514839     History of Changes
Other Study ID Numbers: 150268661
First Posted: August 10, 2007    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014

Keywords provided by Hans-Jürgen Rumpf, University of Luebeck:
Prescription drug use disorder
Brief intervention
General hospital
Motivational Interviewing

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders