Marijuana Abuse and DependenceNCT00594659
Development and Efficacy Test of Computerized Treatment for Marijuana Dependence
A study testing Psychotherapy, Computerized Psychotherapy and Motivational enhancement therapy in people with Marijuana Abuse and Dependence, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
More US residents are dependent on marijuana than on any other illicit drug, and the number enrolled in treatment for marijuana continues to increase such that it is now comparable to that for cocaine and heroin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Abuse and Dependence
- What is being tested?
- Psychotherapy, Computerized Psychotherapy and Motivational enhancement therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Meet criteria for current DSM-IV diagnosis of marijuana abuse or dependence
- Report use of marijuana on at least 40 of the past 90 days
- Severe psychological distress
Who cannot join
- Current dependence on alcohol or any other drug (except nicotine)
- Participation in treatment for alcohol/drug problem
- A legal status which will interfere with participation
- Plans to move out of the area in the next 12 months
- Living with someone who is already enrolled in the project
- Not living within approximately 30 miles of the research site
- Not being fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisel School of Medicine at Dartmouth
Lebanon, New Hampshire, 03756
About this study
More US residents are dependent on marijuana than on any other illicit drug, and the number enrolled in treatment for marijuana continues to increase such that it is now comparable to that for cocaine and heroin. This application seeks to advance the overarching goal to develop and disseminate cost-effective treatments for marijuana dependence that can address this growing problem.
The researchers' previous research suggests that an intervention comprising motivational enhancement, cognitive-behavioral, and contingency-management components (MET/CBT/CM) produces greater rates of successful and durable outcomes than has been demonstrated previously. However, three issues relevant to its efficacy and eventual dissemination must be confronted. First, the outcomes achieved can only be characterized as modest; many individuals do not respond to the treatment and relapse rates remain problematic. Second, access is limited by the availability of trained providers. Third, the cost of delivering the treatment is higher than more traditional outpatient interventions.
Read more
To address these issues, Specific Aim 1 is to develop and test a computer-assisted version of MET/CBT/CM. Computerized treatments have the potential to increase overall effectiveness of treatment services by increasing availability of and access to potent treatments, and by applying innovative technology to enhance outcomes. During Year 1, the intervention will be developed and pilot tested. An interactive program that showed promise in a previous trial for opioid dependence will be modified and enhanced to deliver individualized MET/CBT/CM using effective computer learning technologies. These technologies and access to the MET/CBT/CM program made available via the Internet between treatment sessions and after treatment ends have the potential to promote better learning and more use of coping skills, which in turn can improve outcomes. During Years 2-4 a randomized trial will provide an initial efficacy test of cMET/CBT/CM by comparing it with a brief treatment (MET) and with therapist-delivered MET/CBT/CM. Specific Aim 2 is to learn more about how behavioral treatments like MET/CBT/CM work by focusing on two putative mechanisms of action examined in prior trials: self-efficacy/coping skills and impulsivity/delay discounting. The experimental design will provide a unique opportunity to explore such mechanisms in a novel context- where the therapist is vs. is not a prominent part of the treatment.
The proposed project will address the objectives of NIDA's Behavioral and Integrative Treatment Development Program by providing research on technology-assisted treatment that attempts to make treatment delivery less complex, easier to access, and less costly - while retaining or improving its effectiveness. Findings will inform future studies designed to refine the technology and how it is applied; conduct more definitive effectiveness testing; test generality to other populations including adolescents; and to further advance translation to community settings.
- Conditions
- Marijuana Abuse and Dependence
- Being tested
- Psychotherapy, Computerized Psychotherapy, Motivational enhancement therapy
- Keywords
- Marijuana, Treatment, Behavioral, Computer, Internet
- Medical subject headings
- Marijuana Abuse, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Nine session treatment
Computerized PsychotherapyBehavioural
Nine session computer delivered treatment
Motivational enhancement therapyBehavioural
Two session treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Therapist delivered cognitive behavioral treatment Receives: Behavioral: Psychotherapy |
| 2 | Experimental | Computerized Cognitive Behavioral treatment Receives: Behavioral: Computerized Psychotherapy |
| 3 | Active comparator | Motivational enhancement therapy Receives: Behavioral: Motivational enhancement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consecutive Weeks of Marijuana Abstinence
Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.
Measured: From the start of treatment through the end of the active treatment period, i.e., 12 weeks.
Point Prevalence Abstinence Post Treatment
Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).
Measured: 9 months (from the end of treatment to 9 months post-treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Marijuana Abuse and DependenceStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan J Budney, Ph.D., Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594659
- Sponsor's protocol ID
- 88268
- Other IDs
- 1R01DA023526-01, 1R01DA023526-02, 1R01DA023526-03
- Status last verified
- Dec 2013
- First submitted
- 7 Jan 2008
- Last updated
- 4 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Efficacy Test of Computerized Treatment for Marijuana Dependence
- ClinicalTrials.gov ID
- NCT00594659
- Acronym / sponsor ID
- 88268
- Conditions
- Marijuana Abuse and Dependence
- Keywords
- Marijuana, Treatment, Behavioral, Computer, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 4 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More US residents are dependent on marijuana than on any other illicit drug, and the number enrolled in treatment for marijuana continues to increase such that it is now comparable to that for cocaine and heroin. This application seeks to advance the overarching goal to develop and disseminate cost-effective treatments for marijuana dependence that can address this growing problem.
The researchers' previous research suggests that an intervention comprising motivational enhancement, cognitive-behavioral, and contingency-management components (MET/CBT/CM) produces greater rates of successful and durable outcomes than has been demonstrated previously. However, three issues relevant to its efficacy and eventual dissemination must be confronted. First, the outcomes achieved can only be characterized as modest; many individuals do not respond to the treatment and relapse rates remain problematic. Second, access is limited by the availability of trained providers. Third, the cost of delivering the treatment is higher than more traditional outpatient interventions.
To address these issues, Specific Aim 1 is to develop and test a computer-assisted version of MET/CBT/CM. Computerized treatments have the potential to increase overall effectiveness of treatment services by increasing availability of and access to potent treatments, and by applying innovative technology to enhance outcomes. During Year 1, the intervention will be developed and pilot tested. An interactive program that showed promise in a previous trial for opioid dependence will be modified and enhanced to deliver individualized MET/CBT/CM using effective computer learning technologies. These technologies and access to the MET/CBT/CM program made available via the Internet between treatment sessions and after treatment ends have the potential to promote better learning and more use of coping skills, which in turn can improve outcomes. During Years 2-4 a randomized trial will provide an initial efficacy test of cMET/CBT/CM by comparing it with a brief treatment (MET) and with therapist-delivered MET/CBT/CM. Specific Aim 2 is to learn more about how behavioral treatments like MET/CBT/CM work by focusing on two putative mechanisms of action examined in prior trials: self-efficacy/coping skills and impulsivity/delay discounting. The experimental design will provide a unique opportunity to explore such mechanisms in a novel context- where the therapist is vs. is not a prominent part of the treatment.
The proposed project will address the objectives of NIDA's Behavioral and Integrative Treatment Development Program by providing research on technology-assisted treatment that attempts to make treatment delivery less complex, easier to access, and less costly - while retaining or improving its effectiveness. Findings will inform future studies designed to refine the technology and how it is applied; conduct more definitive effectiveness testing; test generality to other populations including adolescents; and to further advance translation to community settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: PsychotherapyTherapist delivered cognitive behavioral treatment |
| 2 | Experimental | Behavioral: Computerized PsychotherapyComputerized Cognitive Behavioral treatment |
| 3 | Active comparator | Behavioral: Motivational enhancement therapyMotivational enhancement therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Meet criteria for current DSM-IV diagnosis of marijuana abuse or dependence
- Report use of marijuana on at least 40 of the past 90 days
- Severe psychological distress
Key exclusion criteria (7 listed)
- Current dependence on alcohol or any other drug (except nicotine)
- Participation in treatment for alcohol/drug problem
- A legal status which will interfere with participation
- Plans to move out of the area in the next 12 months
- Living with someone who is already enrolled in the project
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 |
|---|---|---|
| PsychotherapyNine session treatment | Behavioural | 1 |
| Computerized PsychotherapyNine session computer delivered treatment | Behavioural | 2 |
| Motivational enhancement therapyTwo session treatment | Behavioural | 3 |
Primary outcome
Consecutive Weeks of Marijuana Abstinence
Time frame: From the start of treatment through the end of the active treatment period, i.e., 12 weeks.
Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.
Point Prevalence Abstinence Post Treatment
Time frame: 9 months (from the end of treatment to 9 months post-treatment).
Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alan J Budney, Ph.D. principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy, Computerized Psychotherapy and Motivational enhancement therapy in people with Marijuana Abuse and Dependence, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Dec 2013. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consecutive Weeks of Marijuana Abstinence (time frame: From the start of treatment through the end of the active treatment period, i.e., 12 weeks.). 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 4 Dec 2013.