Marijuana AbuseNCT00279604
INCA - Intervention and Neuropsychology in Cannabis Abuse
A study testing 'Problem Profile Intervention' vs. WHO-Brief Intervention in people with Marijuana Abuse, run by University Hospital, Bonn at 2 sites in Germany.
Trial 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'. Read more about this study
- Who is it for?
- Ages 16 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Abuse
- What is being tested?
- 'Problem Profile Intervention' vs. WHO-Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2005to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 36 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ASSIST-Score for cannabis consume ≥ 4 ≤ 26
- german mother tongue (or comparable level)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Friedrich-Wilhelms-University, Department of Psychiatry
Bonn, North Rhine-Westphalia, 53105
Christian G Schütz, MD MPH, +49 228 2879664, christian.schütz@ukb.uni-bonn.de
Christian G Schütz, MD MPH
- Recruiting
University of Essen, Department of Psychiatry and Psychotherapy
Essen, North Rhine-Westphalia, 45147
Norbert Scherbaum, MD, +49 201 7227 180, norbert.scherbaum@uni-essen.de
Norbert Scherbaum, MD
About this study
Official title: Targeted Interventions in Cannabis Abuse: Focus on Decision Making (INCA)
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).
- Conditions
- Marijuana Abuse
- Being tested
- 'Problem Profile Intervention' vs. WHO-Brief Intervention
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Problem Profile Intervention' vs. WHO-Brief InterventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis consumption,
motivational change
Secondary outcomes (1)
ASSIST-Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startJul 2005
- Study completionOct 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Christian G Schuetz, MD MPH, Principal investigator, University of Bonn, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279604
- Sponsor's protocol ID
- 01EB0432
- Status last verified
- Apr 2007
- First submitted
- 18 Jan 2006
- Last updated
- 20 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Interventions in Cannabis Abuse: Focus on Decision Making (INCA)
- ClinicalTrials.gov ID
- NCT00279604
- Acronym / sponsor ID
- 01EB0432
- Conditions
- Marijuana Abuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jul 2005
- Study completion
- Oct 2007 (estimated)
- First posted
- 19 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ASSIST-Score for cannabis consume ≥ 4 ≤ 26
- german mother tongue (or comparable level)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Problem Profile Intervention' vs. WHO-Brief Intervention | Behavioural | – |
Primary outcome
Cannabis consumption,
motivational change
1 secondary outcome
ASSIST-Score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian G Schuetz, MD MPH principal investigator
University of Bonn, Department of Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Problem Profile Intervention' vs. WHO-Brief Intervention in people with Marijuana Abuse, run by University Hospital, Bonn at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian G Schuetz, MD MPH (+49 228 287 9664, christian.schütz@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis consumption,. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.