Cannabis Use DisorderRCTTMNCT02277665

Clinical Trial Tobacco Marijuana

A study testing CUD Treatment and Tobacco Treatment in people with Cannabis Use Disorder and Tobacco Use Disorder, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cannabis Use Disorder, Tobacco Use Disorder
What is being tested?: CUD Treatment and Tobacco Treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 3 sitesUnited States
Study dates: 18 Dec 2014to 18 Jan 2017
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Individuals must be 18 years or older
Individuals must meet criteria for the current Diagnostic and Statistical Manual -IV diagnosis of cannabis abuse or dependence, report use of cannabis on at least 45 of the previous 90 days, and report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs
Individual must indicate that they have at least some 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
Use of non-tobacco nicotine
Current participation in structured treatment for substance abuse
Severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder)
Report of a condition that requires seeing a physician before using NRT (e.g., pregnancy or recent heart attack); note: if a participant's physician approves taking NRT, we will consider enrolling them
Legal status that would interfere with participation

Show all 9Show fewer

Living with someone currently enrolled in the project
Not being fluent in English
Not living within 45 miles of the research site

Trial locations and contacts

3 sites in 1 country.

United States3 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
University of Washington School of Social Work
Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Randomized Trial Evaluating Treatment for Cannabis Use Disorders Among Those Who Use Tobacco

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.

This protocol reflects the planned Stage 1, proof-of-concept study that will compare a combined cannabis and tobacco intervention to one that targets CUD only. 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. 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 Use Disorder, Tobacco Use Disorder
Being tested: CUD Treatment, Tobacco Treatment
Keywords: Cannabis Use Disorder, Tobacco Use, Treatment
Medical subject headings: Tobacco Use Disorder, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CUD TreatmentBehavioural
Also called Cognitive Behavioral Therapy and Contingency Management
Tobacco TreatmentBehavioural
Also called Behavioral Counseling plus NRT

Study groups in NCT02277665
Study group	Role	What they receive
CUD Treatment Only	Active comparator	12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD Receives: Behavioral: CUD Treatment
CUD and Tobacco Treatment	Experimental	12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco Receives: Behavioral: CUD Treatment; Behavioral: Tobacco Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Tobacco Quit Attempts
Percent of Participants who made at least one tobacco quit attempt
Measured: Week 12
Tobacco Abstinence
the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12
Measured: Weeks 9-12
Cannabis Abstinence
number of participants who achieved at least one week of documented cannabis abstinence during treatment
Measured: Weeks 1-12
Weeks of Continuous Cannabis Abstinence
Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence
Measured: Weeks 1-12
Treatment Attendance
Attendance operationalized as the number of clinic visits (urine specimens provided)
Measured: 12 weeks
Initiation of Nicotine Replacement Therapy (NRT)
# of participants who initiated NRT during the 24 week study period
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 201418 Jan 2017

First posted29 Oct 2014 (estimated)
Study start18 Dec 2014
Primary completion18 Jan 2017
Study completion18 Jan 2017

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 Cannabis Use DisorderStudies 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: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02277665
Sponsor's protocol ID: STUDY00028307 D14233
Other IDs: 5R01DA032243
Acronym: RCTTM
Status last verified: Dec 2018
First submitted: 27 Oct 2014
Last updated: 8 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1
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Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
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RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
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Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
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All Cannabis Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial Evaluating Treatment for Cannabis Use Disorders Among Those Who Use Tobacco
ClinicalTrials.gov ID: NCT02277665
Acronym / sponsor ID: RCTTM / STUDY00028307 D14233
Conditions: Cannabis Use Disorder, Tobacco Use Disorder
Keywords: Cannabis Use Disorder, Tobacco Use, Treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 18 Dec 2014 (actual)
Primary completion: 18 Jan 2017 (actual)
Study completion: 18 Jan 2017 (actual)
First posted: 29 Oct 2014 (estimated)
Results: Posted 8 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CUD Treatment Only	Active comparator	Behavioral: CUD Treatment12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD
CUD and Tobacco Treatment	Experimental	Behavioral: CUD Treatment, Behavioral: Tobacco Treatment12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Individuals must be 18 years or older
Individuals must meet criteria for the current Diagnostic and Statistical Manual -IV diagnosis of cannabis abuse or dependence, report use of cannabis on at least 45 of the previous 90 days, and report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs
Individual must indicate that they have at least some interest in quitting tobacco in the next 6 months (rating of 2 or more on a 5-point interest scale)

Key exclusion criteria (9 listed)

Current dependence on alcohol or any drug other than tobacco and cannabis
Use of non-tobacco nicotine
Current participation in structured treatment for substance abuse
Severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder)
Report of a condition that requires seeing a physician before using NRT (e.g., pregnancy or recent heart attack); note: if a participant's physician approves taking NRT, we will consider enrolling them

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
CUD TreatmentAlso: Cognitive Behavioral Therapy and Contingency Management	Behavioural	CUD Treatment Only, CUD and Tobacco Treatment
Tobacco TreatmentAlso: Behavioral Counseling plus NRT	Behavioural	CUD and Tobacco Treatment

Primary outcome

Tobacco Quit Attempts
Time frame: Week 12
Percent of Participants who made at least one tobacco quit attempt
Tobacco Abstinence
Time frame: Weeks 9-12
the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12
Cannabis Abstinence
Time frame: Weeks 1-12
number of participants who achieved at least one week of documented cannabis abstinence during treatment
Weeks of Continuous Cannabis Abstinence
Time frame: Weeks 1-12
Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence
Treatment Attendance
Time frame: 12 weeks
Attendance operationalized as the number of clinic visits (urine specimens provided)
Initiation of Nicotine Replacement Therapy (NRT)
Time frame: 24 weeks
# of participants who initiated NRT during the 24 week study period

Results and safety

Results posted to the registry on 8 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CUD Treatment Only	33	33
CUD and Tobacco Treatment	34	34

Primary outcome: Tobacco Quit Attempts

Time frame: Week 12. Count of participants. Unit: Participants

Measure	CUD Treatment Only n = 33	CUD and Tobacco Treatment n = 34
Value	13	17

CUD Treatment Only vs CUD and Tobacco Treatment: Odds Ratio (OR): 0.56 (95% CI .17 to 1.82), p = 0.33, Chi-squared

Primary outcome: Tobacco Abstinence

Time frame: Weeks 9-12. Count of participants. Unit: Participants

Measure	CUD Treatment Only n = 33	CUD and Tobacco Treatment n = 34
Value	1	2

CUD Treatment Only vs CUD and Tobacco Treatment: Odds Ratio (OR): 0.32, p = 0.57, Chi-squared

Primary outcome: Cannabis Abstinence

Time frame: Weeks 1-12. Count of participants. Unit: Participants

Measure	CUD Treatment Only n = 33	CUD and Tobacco Treatment n = 34
Value	12	7

CUD Treatment Only vs CUD and Tobacco Treatment: Odds Ratio (OR): 0.45 (95% CI 0.15 to 1.35), p = 0.16, Chi-squared

Primary outcome: Weeks of Continuous Cannabis Abstinence

Time frame: Weeks 1-12. Mean (Standard Deviation). Unit: weeks

Measure	CUD Treatment Only n = 33	CUD and Tobacco Treatment n = 34
Value	6.1 (3.7)	5.9 (4.0)

CUD Treatment Only vs CUD and Tobacco Treatment: Means Ratio: 0.97 (95% CI 0.66 to 1.42), p = 0.87, Chi-squared

Population analysed: All participants

Adverse events

Time frame: Two years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CUD Treatment Only	0 of 33 (0%)	3 of 33 (9.1%)	0 of 33
CUD and Tobacco Treatment	0 of 34 (0%)	5 of 34 (14.7%)	0 of 34

Limitations and caveats (from the sponsor): Enrollment did not meet planned target numbers, limiting the power to detect differences between conditions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cannabis Use Disorder

Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
Cannabis Dependence, Harmful Use

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-Hitchcock Medical Center

Denise Walker, Ph.D principal investigator

University of Washington School of Social Work

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CUD Treatment and Tobacco Treatment in people with Cannabis Use Disorder and Tobacco Use Disorder, run by Dartmouth-Hitchcock Medical Center at 3 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 3 inclusion and 9 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 8 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 3 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?

Yes. Results are posted in the registry (first posted 8 Jan 2019). 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?

Tobacco Quit Attempts (time frame: Week 12). The study lists 6 primary outcomes in all. 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 NCT02277665.

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 8 Jan 2019.