Brief Intervention for Prescription Drug Misuse in General Hospital

NCT ID: NCT00514839

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2009-02-28

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.

Conditions

Substance-related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

C

Control group receiving a booklet on health behavior

Group Type: NO_INTERVENTION

No interventions assigned to this group

MI

Counselling based on Motivational Interviewing plus individualized feedback

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: 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)

Interventions

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)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal Ministry of Health, Germany

OTHER_GOV

Sponsor Role: collaborator

University of Luebeck

OTHER

Sponsor Role: lead

Responsible Party

Hans-Jürgen Rumpf

PD Dr. Hans-Jürgen Rumpf

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans-Juergen Rumpf, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Luebeck

References

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.

Reference Type: DERIVED

PMID: 19133895 (View on PubMed)

Other Identifiers

150268661

Identifier Type: -

Identifier Source: org_study_id