Cannabis DependenceNCT01834794
Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders
A study testing MET/CBT/CM plus NRT in people with Cannabis Dependence, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
This project aims to develop and test an intervention for the simultaneous treatment of cannabis use disorders and tobacco smoking. This is important because over 50% of adults seeking treatment to help stop cannabis use also smoke tobacco regularly, which decreases their chance for a successful treatment outcome and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cannabis Dependence
- What is being tested?
- MET/CBT/CM plus NRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Jan 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- current DSM-IV diagnosis of cannabis abuse or dependence
- report use of cannabis on at least 45 of previous 90 days
- report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs
- some indication of interest in quitting tobacco in the next 6 months (rating of 2 or more on a 5-point interest scale
Who cannot join
- current dependence on alcohol or any drug other than tobacco and cannabis
- active or recent suicidal ideation
- use of non-tobacco nicotine
- current participation in treatment for substance abuse
- severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder).
- a condition that requires seeing a physician before using NRT (e.g., pregnancy or recent heart attack
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- legal status that would interfere with participation
- living with someone enrolled in the project
- not living within 30 miles of the research site (unless an exception is authorized by the PI)
- not being fluent in english
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geisel School of Medicine at Dartmouth; State Building Site
Concord, New Hampshire, 03301
Geisel School of Medicine at Dartmouth; Rivermill Complex Site
Lebanon, New Hampshire, 03766
About this study
This project aims to develop and test an intervention for the simultaneous treatment of cannabis use disorders and tobacco smoking. This is important because over 50% of adults seeking treatment to help stop cannabis use also smoke tobacco regularly, which decreases their chance for a successful treatment outcome and increases adverse acute and long-term psychosocial and health consequences. The proposed treatment will integrate existing computer-based behavioral interventions for cannabis and tobacco and use nicotine replacement medications to improve outcomes in this difficult to treat clinical population.
Read the detailed description
Approximately 50% of persons seeking treatment for cannabis-use disorders (CUDs) regularly smoke tobacco. Combining tobacco with cannabis has become a common method of smoking cannabis. Similarities of use, and using together, can make quitting difficult. Stopping tobacco simultaneously with cannabis may be beneficial. Little scientific information currently addresses how to best target tobacco smoking during treatment for CUDs. Our long-term goal is to develop an effective protocol for intervening in tobacco smoking without changing cannabis outcomes. A two-phase, Stage 1 therapy development project will accomplish the following: First, a treatment protocol and manual will be developed that integrates a tailored intervention for tobacco smoking with an intervention for CUD (Aim 1). Utilization of web-based counseling programs will standardize delivery of the intervention and foster eventual dissemination. A pilot study will provide an initial test of acceptability and feasibility. Second, a Stage 1, proof-of-concept study will compare this intervention to one that targets CUD only (Aim 2). The hypotheses assert that the intervention (1) will be accepted by the majority of eligible participants (2) will result in more tobacco quit attempts and rates than the CUD-only treatment; and (3) will not adversely affect cannabis outcomes. Last, the project will evaluate the potential of specific moderators of outcomes to predict outcomes and inform subsequent treatment development efforts (Aim 3). If the hypotheses were confirmed, dissemination of this protocol would reduce adverse psychosocial and health consequences of tobacco or cannabis dependence. Findings will inform future development of prevention and intervention strategies.
- Conditions
- Cannabis Dependence
- Being tested
- MET/CBT/CM plus NRT
- Keywords
- Tobacco Use
- Medical subject headings
- Marijuana Abuse, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET/CBT/CM plus NRTBehavioural
Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT.
| Study group | Role | What they receive |
|---|---|---|
| MET/CBT/CM plus NRT | Experimental | Motivational Enhancement Therapy, Cognitive Behavior Therapy, Contingency Management plus Nicotine Replacement Therapy (MET/CBT/CM) + NRT
Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT. Receives: Behavioral: MET/CBT/CM plus NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco Quit Attempts
Sum of 24 hour quit attempts
Measured: Will be assessed for the duration of study, an average of 16 weeks
Secondary outcomes (1)
Cannabis Abstinence: continuous weeks of abstinence achieved during the 12 week treatment period
Urinalysis tests and self-report data will be collected twice per week during participation in the study
Measured: Will be assessed twice per week for the duration of the study treatment period, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2015
- Study completionJan 2015
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 Cannabis 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Alan J. Budney, Dartmouth-Hitchcock Medical Center
- Investigators
- Alan J Budney, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834794
- Sponsor's protocol ID
- 32243 D14201
- Other IDs
- 1R01DA032243-01
- Status last verified
- Jan 2019
- First submitted
- 15 Apr 2013
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee DC, Budney AJ, Brunette MF, Hughes JR, Etter JF, Stanger C. Treatment models for targeting tobacco use during treatment for cannabis use disorder: case series. Addict Behav. 2014 Aug;39(8):1224-30. doi: 10.1016/j.addbeh.2014.04.010. Epub 2014 Apr 13.
PubMed 24813547
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders
- ClinicalTrials.gov ID
- NCT01834794
- Acronym / sponsor ID
- 32243 D14201
- Conditions
- Cannabis Dependence
- Keywords
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Apr 2013 (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.
This project aims to develop and test an intervention for the simultaneous treatment of cannabis use disorders and tobacco smoking. This is important because over 50% of adults seeking treatment to help stop cannabis use also smoke tobacco regularly, which decreases their chance for a successful treatment outcome and increases adverse acute and long-term psychosocial and health consequences. The proposed treatment will integrate existing computer-based behavioral interventions for cannabis and tobacco and use nicotine replacement medications to improve outcomes in this difficult to treat clinical population.
Detailed description
Approximately 50% of persons seeking treatment for cannabis-use disorders (CUDs) regularly smoke tobacco. Combining tobacco with cannabis has become a common method of smoking cannabis. Similarities of use, and using together, can make quitting difficult. Stopping tobacco simultaneously with cannabis may be beneficial. Little scientific information currently addresses how to best target tobacco smoking during treatment for CUDs. Our long-term goal is to develop an effective protocol for intervening in tobacco smoking without changing cannabis outcomes. A two-phase, Stage 1 therapy development project will accomplish the following: First, a treatment protocol and manual will be developed that integrates a tailored intervention for tobacco smoking with an intervention for CUD (Aim 1). Utilization of web-based counseling programs will standardize delivery of the intervention and foster eventual dissemination. A pilot study will provide an initial test of acceptability and feasibility. Second, a Stage 1, proof-of-concept study will compare this intervention to one that targets CUD only (Aim 2). The hypotheses assert that the intervention (1) will be accepted by the majority of eligible participants (2) will result in more tobacco quit attempts and rates than the CUD-only treatment; and (3) will not adversely affect cannabis outcomes. Last, the project will evaluate the potential of specific moderators of outcomes to predict outcomes and inform subsequent treatment development efforts (Aim 3). If the hypotheses were confirmed, dissemination of this protocol would reduce adverse psychosocial and health consequences of tobacco or cannabis dependence. Findings will inform future development of prevention and intervention strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MET/CBT/CM plus NRT | Experimental | Behavioral: MET/CBT/CM plus NRTMotivational Enhancement Therapy, Cognitive Behavior Therapy, Contingency Management plus Nicotine Replacement Therapy (MET/CBT/CM) + NRT Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years old
- current DSM-IV diagnosis of cannabis abuse or dependence
- report use of cannabis on at least 45 of previous 90 days
- report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs
- some indication of interest in quitting tobacco in the next 6 months (rating of 2 or more on a 5-point interest scale
Key exclusion criteria (10 listed)
- current dependence on alcohol or any drug other than tobacco and cannabis
- active or recent suicidal ideation
- use of non-tobacco nicotine
- current participation in treatment for substance abuse
- severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic 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 |
|---|---|---|
| MET/CBT/CM plus NRTBehavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT. | Behavioural | MET/CBT/CM plus NRT |
Primary outcome
Tobacco Quit Attempts
Time frame: Will be assessed for the duration of study, an average of 16 weeks
Sum of 24 hour quit attempts
1 secondary outcome
Cannabis Abstinence: continuous weeks of abstinence achieved during the 12 week treatment period
Time frame: Will be assessed twice per week for the duration of the study treatment period, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Results publication: PubMed 24813547Lee DC, Budney AJ, Brunette MF, Hughes JR, Etter JF, Stanger C. Treatment models for targeting tobacco use during treatment for cannabis use disorder: case series. Addict Behav. 2014 Aug;39(8):1224-30. doi: 10.1016/j.addbeh.2014.04.010. Epub 2014 Apr 13.
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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 principal investigator
Dartmouth-Hitchcock Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MET/CBT/CM plus NRT in people with Cannabis Dependence, run by Dartmouth-Hitchcock Medical Center at 2 sites 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 5 inclusion and 10 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 14 Jan 2019. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tobacco Quit Attempts (time frame: Will be assessed for the duration of study, an average of 16 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 NCT01834794, 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 14 Jan 2019.