NCT00514839

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

2.8 years

First QC Date

August 9, 2007

Last Update Submit

April 1, 2014

Conditions

Keywords

Prescription drug use disorderBrief interventionGeneral hospitalMotivational Interviewing

Outcome Measures

Primary Outcomes (3)

  • Discontinuation of consumption of prescription drugs

    one year

  • Reduction of consumption of prescription drugs

    one year

  • Utilization of formal help

    one year

Secondary Outcomes (1)

  • Readiness to change consumption of prescription drugs

    one year

Study Arms (2)

C

NO INTERVENTION

Control group receiving a booklet on health behavior

MI

EXPERIMENTAL

Counselling based on Motivational Interviewing plus individualized feedback

Behavioral: Motivational Interviewing

Interventions

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)

MI

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prescription drug abuse
  • Prescription drug dependence
  • Regular prescription drug consumption (\>60 times/last three months)

You may not qualify if:

  • Current treatment for substance abuse problems
  • Terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hans-Juergen Rumpf, Ph.D.

    University of Luebeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Hans-Jürgen Rumpf

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 10, 2007

Study Start

November 1, 2005

Primary Completion

August 1, 2008

Study Completion

February 1, 2009

Last Updated

April 2, 2014

Record last verified: 2014-04