Clinical trial NCT00514839: Brief Intervention for Prescription Drug Misuse in General Hospital
Official title: Brief Intervention for Regular Prescription Drug Use and Prescription Drug Use Disorders in General Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance-related Disorders
Keywords: Prescription drug use disorder
Brief intervention
General hospital
Motivational Interviewing
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Health, Germany
First posted: 2007-08-10
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Discontinuation of consumption of prescription drugs
timeFrame: one year
measure: Reduction of consumption of prescription drugs
timeFrame: one year
measure: Utilization of formal help
timeFrame: one year
Secondary outcomes:
measure: Readiness to change consumption of prescription drugs
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: University of Luebeck
name: Hans-Juergen Rumpf, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.