INCA - Intervention and Neuropsychology in Cannabis Abuse

Sponsor
University Hospital, Bonn (Other)
Overall Status
Unknown status
CT.gov ID
NCT00279604
Collaborator
German Federal Ministry of Education and Research (Other)
160
2
27
80
3

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 'Problem Profile Intervention' vs. WHO-Brief Intervention
N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Targeted Interventions in Cannabis Abuse: Focus on Decision Making (INCA)
Study Start Date :
Jul 1, 2005
Anticipated Study Completion Date :
Oct 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Cannabis consumption, []

  2. motivational change []

Secondary Outcome Measures

  1. ASSIST-Score []

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 36 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Friedrich-Wilhelms-University, Department of Psychiatry Bonn NRW Germany 53105
2 University of Essen, Department of Psychiatry and Psychotherapy Essen NRW Germany 45147

Sponsors and Collaborators

  • University Hospital, Bonn
  • German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Christian G Schuetz, MD MPH, University of Bonn, Department of Psychiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00279604
Other Study ID Numbers:
  • 01EB0432
First Posted:
Jan 19, 2006
Last Update Posted:
Apr 20, 2007
Last Verified:
Apr 1, 2007
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2007