Brief Intervention for Prescription Drug Misuse in General Hospital

Substance-related Disorders Clinical Trial

— MIMIK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514839
• Other study ID #: 150268661
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2007
• Last updated: April 1, 2014
• Start date: November 2005
• Est. completion date: February 2009

Study information

• Verified date: April 2014
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-related Disorders

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	Federal Ministry of Health, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discontinuation of consumption of prescription drugs		one year	No
Primary	Reduction of consumption of prescription drugs		one year	No
Primary	Utilization of formal help		one year	No
Secondary	Readiness to change consumption of prescription drugs		one year	No