Marijuana AbuseNCT00878852
Efficacy of Contingency Management in the Treatment of Adolescents With Cannabis Use Disorders
A study testing Standard treatment and Standard Treatment Plus Contingency Management Program in people with Marijuana Abuse, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Cannabis use among Spanish adolescents has been increasing in the last decade. It has been related to poor school achievement, delinquency, substance use and psychiatric disorders. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Marijuana Abuse
- What is being tested?
- Standard treatment and Standard Treatment Plus Contingency Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2009to Dec 2010
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presence of DSM-IV-TR criteria of cannabis abuse and/or dependence
- Signed informed consent
Who cannot join
- Mental retardation
- Presence of a substance use disorder other than nicotine or cannabis
- Severe or unstable medical
- Presence at the moment of inclusion of severe acute psychopathology (acute psychotic symptoms, severe depressive symptoms, suicidal ideation)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic Barcelona
Barcelona, Barcelona, 08015
About this study
Official title: Efficacy of a Contingency Management Program in the Treatment of Adolescents With Cannabis Use Disorders in a Child and Adolescent Psychiatry and Psychology Department
Cannabis use among Spanish adolescents has been increasing in the last decade. It has been related to poor school achievement, delinquency, substance use and psychiatric disorders. Furthermore, psychoactive substance use in adolescents presenting psychiatric disorders can result in the development of substance use disorders or the worsening of psychopathology. Thus, there's an urge to develop efficient interventions in the treatment of these disorders. Therapeutic approaches based on cognitive-behavioural therapy and motivational interviewing have demonstrated a limited efficacy in this population. Programs based on contingency management have been reported to be useful both in adult and adolescents, too. But it still remains unclear whether a combination of these therapeutic approaches is feasible and brings a better cost-benefit relation.
The investigators' project aims to evaluate the added benefits of supplementing a standard intervention on cannabis use, based on combined approach that includes motivational and cognitive-behavioural elements, with a contingency management program. Therefore, pre and post-treatment evaluation will be carried forward in a sample of 30 adolescents (aged 12-18) that initiate treatment for cannabis use related disorder at the Child and Adolescent Psychiatry Department of the Hospital Clinic in Barcelona. Participants will be randomly assigned to a standard treatment group or an experimental group in which standard treatment will be supplemented with a contingency management protocol. As a secondary objective, a prospective assessment of neuropsychological performance related to cannabis use or abstinence will be carried forward.
- Conditions
- Marijuana Abuse
- Being tested
- Standard treatment, Standard Treatment Plus Contingency Management Program
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatmentBehavioural
Participants will be randomly assigned to a standard treatment group. Patients allocated to this group will receive active treatment in form of 12-session intervention program. This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001). Intervention includes Motivational interviewing (2 sessions) and Cognitive behavioral therapy
Standard Treatment Plus Contingency Management ProgramBehavioural
Participants assigned to this group will receive active treatment in form of 12-session intervention program. This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001). Intervention includes Motivational interviewing (2 sessions) and Cognitive behavioral therapy (10 sessions). This treatment protocol will be supplemented with a contingency management intervention. Intervention will consist in a voucher program: negative urine-screens will be rewarded with vouchers. Voucher will have an increasing value. At the end of the program, vouchers can be changed by gifts. Potential gifts will be selected by the therapists and will be related to pro-social activities, aiming to change preexisting risk behaviours.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Participants will be randomly assigned to a standard treatment group. Patients allocated to this group will receive active treatment in form of a 12-session intervention program. This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001) Receives: Behavioral: Standard treatment |
| Experimental | Experimental | Participants randomly assigned to this group will received standard treatment (including 12 session therapy program) supplemented with an intervention with a contingency management program, designed to improve adherence and efficacy of the treatment program. Receives: Behavioral: Standard Treatment Plus Contingency Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of marijuana active users
Measured: 12 weeks
Secondary outcomes (3)
Percentage of negative urine-screens
Measured: 12 weeks
Percentage of completed intervention sessions
Measured: 12 weeks
Scores in psychopathology and drug scales (T-ASI, SDQ, BDI, Cannabis Problem Questionnaire)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Marijuana AbuseStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Javier Goti, M.D, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878852
- Sponsor's protocol ID
- PI08/90331
- Other IDs
- 4363/2008 (Ethics Comitee HCP)
- Status last verified
- May 2009
- First submitted
- 8 Apr 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Stephens RS, Babor TF, Kadden R, Miller M; Marijuana Treatment Project Research Group. The Marijuana Treatment Project: rationale, design and participant characteristics. Addiction. 2002 Dec;97 Suppl 1:109-24. doi: 10.1046/j.1360-0443.97.s01.6.x.
PubMed 12460133
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Contingency Management Program in the Treatment of Adolescents With Cannabis Use Disorders in a Child and Adolescent Psychiatry and Psychology Department
- ClinicalTrials.gov ID
- NCT00878852
- Acronym / sponsor ID
- PI08/90331
- Conditions
- Marijuana Abuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (estimated)
- First posted
- 9 Apr 2009 (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.
Cannabis use among Spanish adolescents has been increasing in the last decade. It has been related to poor school achievement, delinquency, substance use and psychiatric disorders. Furthermore, psychoactive substance use in adolescents presenting psychiatric disorders can result in the development of substance use disorders or the worsening of psychopathology. Thus, there's an urge to develop efficient interventions in the treatment of these disorders. Therapeutic approaches based on cognitive-behavioural therapy and motivational interviewing have demonstrated a limited efficacy in this population. Programs based on contingency management have been reported to be useful both in adult and adolescents, too. But it still remains unclear whether a combination of these therapeutic approaches is feasible and brings a better cost-benefit relation.
The investigators' project aims to evaluate the added benefits of supplementing a standard intervention on cannabis use, based on combined approach that includes motivational and cognitive-behavioural elements, with a contingency management program. Therefore, pre and post-treatment evaluation will be carried forward in a sample of 30 adolescents (aged 12-18) that initiate treatment for cannabis use related disorder at the Child and Adolescent Psychiatry Department of the Hospital Clinic in Barcelona. Participants will be randomly assigned to a standard treatment group or an experimental group in which standard treatment will be supplemented with a contingency management protocol. As a secondary objective, a prospective assessment of neuropsychological performance related to cannabis use or abstinence will be carried forward.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Behavioral: Standard treatmentParticipants will be randomly assigned to a standard treatment group. Patients allocated to this group will receive active treatment in form of a 12-session intervention program. This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001) |
| Experimental | Experimental | Behavioral: Standard Treatment Plus Contingency Management ProgramParticipants randomly assigned to this group will received standard treatment (including 12 session therapy program) supplemented with an intervention with a contingency management program, designed to improve adherence and efficacy of the treatment program. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Presence of DSM-IV-TR criteria of cannabis abuse and/or dependence
- Signed informed consent
Key exclusion criteria (4 listed)
- Mental retardation
- Presence of a substance use disorder other than nicotine or cannabis
- Severe or unstable medical
- Presence at the moment of inclusion of severe acute psychopathology (acute psychotic symptoms, severe depressive symptoms, suicidal ideation)
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 |
|---|---|---|
| Standard treatmentParticipants will be randomly assigned to a standard treatment group. Patients allocated to this group will receive active treatment in form of 12-session intervention program. This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001). Intervention includes Motivational interviewing (2 sessions) and Cognitive behavioral therapy | Behavioural | Standard treatment |
| Standard Treatment Plus Contingency Management ProgramParticipants assigned to this group will receive active treatment in form of 12-session intervention program. This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001). Intervention includes Motivational interviewing (2 sessions) and Cognitive behavioral therapy (10 sessions). This treatment protocol will be supplemented with a contingency management intervention. Intervention will consist in a voucher program: negative urine-screens will be rewarded with vouchers. Voucher will have an increasing value. At the end of the program, vouchers can be changed by gifts. Potential gifts will be selected by the therapists and will be related to pro-social activities, aiming to change preexisting risk behaviours. | Behavioural | Experimental |
Primary outcome
Percentage of marijuana active users
Time frame: 12 weeks
3 secondary outcomes
Percentage of negative urine-screens
Time frame: 12 weeks
Percentage of completed intervention sessions
Time frame: 12 weeks
Scores in psychopathology and drug scales (T-ASI, SDQ, BDI, Cannabis Problem Questionnaire)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2009.
- Background: PubMed 12460133Stephens RS, Babor TF, Kadden R, Miller M; Marijuana Treatment Project Research Group. The Marijuana Treatment Project: rationale, design and participant characteristics. Addiction. 2002 Dec;97 Suppl 1:109-24. doi: 10.1046/j.1360-0443.97.s01.6.x.
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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.
Javier Goti, M.D principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard treatment and Standard Treatment Plus Contingency Management Program in people with Marijuana Abuse, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 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 21 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 Javier Goti, M.D (0034932279970, jgoti@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of marijuana active users (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878852, which also lists 1 linked publication.
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 21 May 2009.