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INCA - Intervention and Neuropsychology in Cannabis Abuse

Primary Purpose

Marijuana Abuse

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
'Problem Profile Intervention' vs. WHO-Brief Intervention
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse

Eligibility Criteria

16 Years - 36 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: ASSIST-Score for cannabis consume ≥ 4 ≤ 26 german mother tongue (or comparable level) Exclusion Criteria: major current psychiatric disorder (e.g. psychosis) addiction to other illegal drugs or alcohol recent or current intravenous drug use CNS-affecting medication current psychotherapy, other treatment for substance use disorder exclusion criteria for fMRI-part: left-handedness medication (birth control pill, thyroid gland hormones possible) internistic illnesses (hypertension, diabetes, diseases of lungs) metallic implants (cardiac pacemaker, ferromagnetic object implanted through surgical intervention or accident, large-area tattoos) history of serious trauma claustrophobia gestation

Sites / Locations

  • Friedrich-Wilhelms-University, Department of PsychiatryRecruiting
  • University of Essen, Department of Psychiatry and PsychotherapyRecruiting

Outcomes

Primary Outcome Measures

Cannabis consumption,
motivational change

Secondary Outcome Measures

ASSIST-Score

Full Information

First Posted
January 18, 2006
Last Updated
April 19, 2007
Sponsor
University Hospital, Bonn
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT00279604
Brief Title
INCA - Intervention and Neuropsychology in Cannabis Abuse
Official Title
Targeted Interventions in Cannabis Abuse: Focus on Decision Making (INCA)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bonn
Collaborators
German Federal Ministry of Education and Research

4. Oversight

5. Study Description

Brief Summary
INCA (Intervention and Neuropsychology of Cannabis Abuse) is a study combining two research goals. One is to study efficacy of a short intervention the 'Problem Profile Intervention', which utilizes individual feedback from a 'substance problem check-up'. Subjects will randomly receive the 'Problem Profile Intervention' or the WHO Brief Intervention, a brief intervention, which has been shown to be efficacious. Currently efficiency studies are under way. The WHO Brief Intervention has been translated into German by our group. In contrast to most other cannabis intervention studies the current study is focussed on cannabis abusers not so much cannabis-dependent subjects. A total of 160 subjects are to be recruited. Half of them will randomly receive either the Problem Profile Intervention or the WHO Brief Intervention (active control). A total of 25% of subjects from each group will be placed on a 3 months waiting list before receiving the intervention (inactive control). Intervention outcome will be assessed three months, six month and 12 months after the intervention. We hypothesize cannabis use to be reduced by 25% by the 'Problem Profile Intervention'. The second aim of the study is to study mechanism of substance abuse. Initial results from own studies and data from other groups point to executive cognitive functions as a subtle but important factor that can be compromised in cannabis users (Verdejo-Garcia et al., 2004; Garavan and Stout, 2005). Using an fMRI-study, we intend to examine a subgroup of our subjects on a specific aspect of executive functioning that has recently received major interest in drug research: Decision-making capability, or risk-taking behaviour, respectively (e.g. Ernst and Paulus, 2005).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
'Problem Profile Intervention' vs. WHO-Brief Intervention
Primary Outcome Measure Information:
Title
Cannabis consumption,
Title
motivational change
Secondary Outcome Measure Information:
Title
ASSIST-Score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASSIST-Score for cannabis consume ≥ 4 ≤ 26 german mother tongue (or comparable level) Exclusion Criteria: major current psychiatric disorder (e.g. psychosis) addiction to other illegal drugs or alcohol recent or current intravenous drug use CNS-affecting medication current psychotherapy, other treatment for substance use disorder exclusion criteria for fMRI-part: left-handedness medication (birth control pill, thyroid gland hormones possible) internistic illnesses (hypertension, diabetes, diseases of lungs) metallic implants (cardiac pacemaker, ferromagnetic object implanted through surgical intervention or accident, large-area tattoos) history of serious trauma claustrophobia gestation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian G Schuetz, MD MPH
Phone
+49 228 287 9664
Email
christian.schütz@ukb.uni-bonn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian G Schuetz, MD MPH
Organizational Affiliation
University of Bonn, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich-Wilhelms-University, Department of Psychiatry
City
Bonn
State/Province
NRW
ZIP/Postal Code
53105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian G Schütz, MD MPH
Phone
+49 228 2879664
Email
christian.schütz@ukb.uni-bonn.de
First Name & Middle Initial & Last Name & Degree
Christian G Schütz, MD MPH
Facility Name
University of Essen, Department of Psychiatry and Psychotherapy
City
Essen
State/Province
NRW
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Scherbaum, MD
Phone
+49 201 7227 180
Email
norbert.scherbaum@uni-essen.de
First Name & Middle Initial & Last Name & Degree
Norbert Scherbaum, MD

12. IPD Sharing Statement

Learn more about this trial

INCA - Intervention and Neuropsychology in Cannabis Abuse

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