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INCA - Intervention and Neuropsychology in Cannabis Abuse

NCT ID: NCT00279604

Last Updated: 2007-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Marijuana Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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'Problem Profile Intervention' vs. WHO-Brief Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bonn

OTHER

Sponsor Role lead

Principal Investigators

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Christian G Schuetz, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Bonn, Department of Psychiatry

Locations

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Friedrich-Wilhelms-University, Department of Psychiatry

Bonn, North Rhine-Westphalia, Germany

Site Status RECRUITING

University of Essen, Department of Psychiatry and Psychotherapy

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christian G Schuetz, MD MPH

Role: CONTACT

christian.schü[email protected]
+49 228 287 9664

Facility Contacts

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Christian G Schütz, MD MPH

Role: primary

christian.schü[email protected]
+49 228 2879664

Norbert Scherbaum, MD

Role: primary

[email protected]
+49 201 7227 180

Other Identifiers

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01EB0432

Identifier Type: -

Identifier Source: org_study_id