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Completed

NCT Number: NCT00514839

Brief Intervention for Prescription Drug Misuse in General Hospital

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.

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

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 outcomes

  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 outcomes

  1. Readiness to change consumption of prescription drugs

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

  • Federal Ministry of Health, Germany

Registry information

Official study title

Brief Intervention for Regular Prescription Drug Use and Prescription Drug Use Disorders in General Hospital

Acronym: MIMIK

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Aug 10, 2007
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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