Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DA032243 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CUD Treatment Only | Active Comparator | 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CUD Treatment | Behavioral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco Quit Attempts | Percent of Participants who made at least one tobacco quit attempt | Week 12 |
| Tobacco Abstinence | the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12 | Weeks 9-12 |
| Cannabis Abstinence | number of participants who achieved at least one week of documented cannabis abstinence during treatment | Weeks 1-12 |
| Weeks of Continuous Cannabis Abstinence | Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence | Weeks 1-12 |
| Treatment Attendance | Attendance operationalized as the number of clinic visits (urine specimens provided) | 12 weeks |
| Initiation of Nicotine Replacement Therapy (NRT) | # of participants who initiated NRT during the 24 week study period | 24 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan J Budney, Ph.D | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Denise Walker, Ph.D | University of Washington School of Social Work | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisel School of Medicine at Dartmouth; State Building Site | Concord | New Hampshire | 03301 | United States | ||
All those who enrolled were assigned to a treatment condition
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CUD Treatment Only | 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CUD Treatment Only | 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment |
| BG001 | CUD and Tobacco Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tobacco Quit Attempts | Percent of Participants who made at least one tobacco quit attempt | Posted | Count of Participants | Participants | Week 12 |
|
Two years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CUD Treatment Only | 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pruritus | Endocrine disorders | Systematic Assessment |
Enrollment did not meet planned target numbers, limiting the power to detect differences between conditions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alan J. Budney | Dartmouth-Hitchcock | 603-646-7088 | alan.j.budney@dartmouth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2018 | Dec 17, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tobacco Treatment | Behavioral |
|
|
| Geisel School of Medicine at Dartmouth; Rivermill Complex Site |
| Lebanon |
| New Hampshire |
| 03766 |
| United States |
| University of Washington School of Social Work | Seattle | Washington | 98105 | United States |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Tobacco Abstinence | the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12 | Posted | Count of Participants | Participants | Weeks 9-12 |
|
|
|
|
| Primary | Cannabis Abstinence | number of participants who achieved at least one week of documented cannabis abstinence during treatment | Posted | Count of Participants | Participants | Weeks 1-12 |
|
|
|
|
| Primary | Weeks of Continuous Cannabis Abstinence | Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence | All participants | Posted | Mean | Standard Deviation | weeks | Weeks 1-12 |
|
|
|
|
| Primary | Treatment Attendance | Attendance operationalized as the number of clinic visits (urine specimens provided) | Posted | Mean | Standard Deviation | visits | 12 weeks |
|
|
|
|
| Primary | Initiation of Nicotine Replacement Therapy (NRT) | # of participants who initiated NRT during the 24 week study period | All participants included in analysis | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 3 |
| 33 |
| EG001 | 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 | 0 | 34 | 0 | 34 | 5 | 34 |
Not provided
Not provided