Cannabis Use Disorder, Tobacco Use Disorder
Conditions
Keywords
Cannabis Use Disorder, Tobacco Use, Treatment
Brief summary
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.
Interventions
BEHAVIORALCUD Treatment
BEHAVIORALTobacco Treatment
Sponsors
National Institute on Drug Abuse (NIDA)
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Individuals must be 18 years or older 2. 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 3. 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)
Exclusion criteria
1. Current dependence on alcohol or any drug other than tobacco and cannabis 2. Use of non-tobacco nicotine 3. Current participation in structured treatment for substance abuse 4. Severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder) 5. 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 6. Legal status that would interfere with participation 7. Living with someone currently enrolled in the project 8. Not being fluent in English 9. Not living within 45 miles of the research site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco Quit Attempts | Week 12 | Percent of Participants who made at least one tobacco quit attempt |
| Tobacco Abstinence | Weeks 9-12 | the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12 |
| Cannabis Abstinence | Weeks 1-12 | number of participants who achieved at least one week of documented cannabis abstinence during treatment |
| Weeks of Continuous Cannabis Abstinence | Weeks 1-12 | Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence |
| Treatment Attendance | 12 weeks | Attendance operationalized as the number of clinic visits (urine specimens provided) |
| Initiation of Nicotine Replacement Therapy (NRT) | 24 weeks | \# of participants who initiated NRT during the 24 week study period |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between 12/2014 to 09/2016 at Dartmouth College and the University of Washington. Participants were recruited from ads posted online (Craigslist, Facebook), in newspapers, on radio, community posters, and notices to service agencies. All activities occurred at stand-alone, University associated research clinics.
Pre-assignment details
All those who enrolled were assigned to a treatment condition
Participants by arm
| Arm | Count |
|---|---|
| CUD Treatment Only 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD
CUD Treatment | 33 |
| CUD and Tobacco Treatment 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
CUD Treatment
Tobacco Treatment | 34 |
| Total | 67 |
Baseline characteristics
| Characteristic | CUD Treatment Only | Total | CUD and Tobacco Treatment |
|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 12.2 | 34.0 years STANDARD_DEVIATION 11.6 | 31.7 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 22 Participants | 43 Participants | 21 Participants |
| Region of Enrollment United States | 33 participants | 67 participants | 34 participants |
| Sex: Female, Male Female | 8 Participants | 19 Participants | 11 Participants |
| Sex: Female, Male Male | 25 Participants | 48 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 34 |
| other Total, other adverse events | 3 / 33 | 5 / 34 |
| serious Total, serious adverse events | 0 / 33 | 0 / 34 |
Outcome results
Primary
Cannabis Abstinence
number of participants who achieved at least one week of documented cannabis abstinence during treatment
Time frame: Weeks 1-12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CUD Treatment Only | Cannabis Abstinence | 12 Participants |
| CUD and Tobacco Treatment | Cannabis Abstinence | 7 Participants |
p-value: =0.1695% CI: [0.15, 1.35]Chi-squared
Primary
Initiation of Nicotine Replacement Therapy (NRT)
\# of participants who initiated NRT during the 24 week study period
Time frame: 24 weeks
Population: All participants included in analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CUD Treatment Only | Initiation of Nicotine Replacement Therapy (NRT) | 6 Participants |
| CUD and Tobacco Treatment | Initiation of Nicotine Replacement Therapy (NRT) | 14 Participants |
p-value: 0.04Chi-squared
Primary
Tobacco Abstinence
the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12
Time frame: Weeks 9-12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CUD Treatment Only | Tobacco Abstinence | 1 Participants |
| CUD and Tobacco Treatment | Tobacco Abstinence | 2 Participants |
p-value: 0.57Chi-squared
Primary
Tobacco Quit Attempts
Percent of Participants who made at least one tobacco quit attempt
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CUD Treatment Only | Tobacco Quit Attempts | 13 Participants |
| CUD and Tobacco Treatment | Tobacco Quit Attempts | 17 Participants |
p-value: =0.3395% CI: [0.17, 1.82]Chi-squared
Primary
Treatment Attendance
Attendance operationalized as the number of clinic visits (urine specimens provided)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CUD Treatment Only | Treatment Attendance | 11.3 visits | Standard Deviation 9 |
| CUD and Tobacco Treatment | Treatment Attendance | 9.7 visits | Standard Deviation 8.9 |
p-value: 0.46t-test, 2 sided
Primary
Weeks of Continuous Cannabis Abstinence
Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence
Time frame: Weeks 1-12
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CUD Treatment Only | Weeks of Continuous Cannabis Abstinence | 6.1 weeks | Standard Deviation 3.7 |
| CUD and Tobacco Treatment | Weeks of Continuous Cannabis Abstinence | 5.9 weeks | Standard Deviation 4 |
p-value: 0.8795% CI: [0.66, 1.42]Chi-squared