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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DA045099-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Effective and durable treatments for cannabis use disorder remain elusive. Given the increasing prevalence rates of cannabis use and CUD nationwide, investigation of novel treatments is warranted. Implicit cognitive processing is an emerging, and potentially critical therapeutic target.
Cognitive models of addiction posit an override of explicit control-related cognitive processes by implicit reward-driven processes resulting from chronic drug exposure. One form of implicit cognitive processing is approach bias, or, the automatic tendency to approach rather than avoid drug cues, which has been identified for alcohol, nicotine, opioids, and cannabis. Cannabis approach bias predicts increased cannabis use, dependence severity, and cannabis-related problems among heavy cannabis users. Approach bias modification (ABM) is a novel treatment approach that seeks to reduce approach bias by attenuating the incentive-salience of drug cues, and subsequently, drug cue reactivity and drug use. ABM has been shown to reduce relapse rates in alcohol dependent adults by 10-13% at one-year follow-up, and dependence severity in nicotine dependent adults. Our pilot data suggests that ABM may also reduce cannabis craving and that gender may moderate the effect of ABM on cannabis sessions per day in non-treatment seeking adults with CUD. A recent fMRI study with alcohol-dependent adults found decreased mesolimbic activation in participants who received ABM compared to sham-control participants. ABM appears to target implicit reward-driven processes, and could be an effective adjunct to traditional psychosocial and/or future pharmacological interventions that target explicit control-related processes.
Building on our promising feasibility data, the proposed K23 research study will examine the effects of ABM on cue-reactivity and cannabis outcomes in a four-session randomized, double-blind, sham-controlled pilot treatment trial. One-hundred and six (106) treatment-seeking adults with moderate to severe CUD will be randomized to receive either MET/CBT plus ABM or Motivational Enhancement Therapy/Cognitive Behavioral Therapy(MET/CBT) plus sham-ABM. An equal number of men and women will be recruited and randomization will be stratified by gender. ABM sessions will occur following each of the three weekly MET/CBT therapy sessions. Primary outcomes will include cannabis cue-reactivity and cannabis use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active ABM + CBT/MET | Experimental | Participants in the Active ABM condition will receive approach bias modification (ABM) training sessions aimed at reducing cognitive bias for cannabis cues. All participants will receive MET/CBT therapy. |
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| Sham ABM + CBT/MET | Sham Comparator | Participants in the Sham ABM condition will undergo similar computerized tasks without the manipulation of response contingencies that target modification of approach bias. All participants will receive MET/CBT therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Approach Bias Modification (ABM) | Behavioral | Approach bias modification (ABM) is a novel treatment that involves retraining the implicit action tendency to approach a drug cue by manipulating contingencies in a stimulus-response paradigm. |
| Measure | Description | Time Frame |
|---|---|---|
| Cannabis Approach Bias | Using a cue-reactivity paradigm, we will evaluate the efficacy of approach bias modification on cannabis approach bias. Participants are presented with cannabis related and neutral images on a computer screen and are asked to push or pull a joystick in response to a non-content related stimulus feature (i.e. image border color - blue or yellow). Joystick movement activates a zooming feature, which has been shown to effectively simulate approach (pull-zoom in) and avoidance (push-zoom out), and reaction times are calculated from image onset to zoom off-screen. Participants are asked to respond as quickly and accurately as possible. Cannabis approach bias is computed by subtracting "pull CB cue" reaction times (RTs) from "push CB cue" RTs (CBpushRT - CBpullRT); a positive value thus indicates greater cannabis approach bias. Approach bias assessments occurred at 3 time points: baseline (pre-assessment), end of study (post-assessment), and follow-up (follow-up assessment). During t | Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Days Using Cannabis | Using self-report we will evaluate the efficacy of ABM on percent days using cannabis, measurements will be summarized at end of study treatment and at the follow up visit. | Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks) |
| Marijuana Craving Questionnaire Total Score (Craving) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian J Sherman, Ph.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medial University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active ABM + CBT/MET | Participants in the Active ABM condition will receive approach bias modification (ABM) training sessions aimed at reducing cognitive bias for cannabis cues. All participants will receive MET/CBT therapy. Approach Bias Modification (ABM): Approach bias modification (ABM) is a novel treatment that involves retraining the implicit action tendency to approach a drug cue by manipulating contingencies in a stimulus-response paradigm. Psychosocial therapy for cannabis use disorder.: All participants will receive psychosocial therapy for cannabis use disorder. |
| FG001 | Sham ABM + CBT/MET | Participants in the Sham ABM condition will undergo similar computerized tasks without the manipulation of response contingencies that target modification of approach bias. All participants will receive MET/CBT therapy. Sham ABM: Sham ABM involves similar computerized procedures that mimic the active experimental condition, but do not involve manipulation of response contingencies and thus it does not contain any "active" intervention. Psychosocial therapy for cannabis use disorder.: All participants will receive psychosocial therapy for cannabis use disorder. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline analysis population consists of all participants successfully randomized either active or sham condition.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active ABM + CBT/MET | Participants in the Active ABM condition will receive approach bias modification (ABM) training sessions aimed at reducing cognitive bias for cannabis cues. All participants will receive MET/CBT therapy. Approach Bias Modification (ABM): Approach bias modification (ABM) is a novel treatment that involves retraining the implicit action tendency to approach a drug cue by manipulating contingencies in a stimulus-response paradigm. Psychosocial therapy for cannabis use disorder.: All participants will receive psychosocial therapy for cannabis use disorder. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Cannabis Approach Bias | Using a cue-reactivity paradigm, we will evaluate the efficacy of approach bias modification on cannabis approach bias. Participants are presented with cannabis related and neutral images on a computer screen and are asked to push or pull a joystick in response to a non-content related stimulus feature (i.e. image border color - blue or yellow). Joystick movement activates a zooming feature, which has been shown to effectively simulate approach (pull-zoom in) and avoidance (push-zoom out), and reaction times are calculated from image onset to zoom off-screen. Participants are asked to respond as quickly and accurately as possible. Cannabis approach bias is computed by subtracting "pull CB cue" reaction times (RTs) from "push CB cue" RTs (CBpushRT - CBpullRT); a positive value thus indicates greater cannabis approach bias. Approach bias assessments occurred at 3 time points: baseline (pre-assessment), end of study (post-assessment), and follow-up (follow-up assessment). During t | All randomized participants with at least one post randomization visit. | Posted | Mean | Standard Deviation | seconds | Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks) |
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active ABM + CBT/MET | Participants in the Active ABM condition will receive approach bias modification (ABM) training sessions aimed at reducing cognitive bias for cannabis cues. All participants will receive MET/CBT therapy. Approach Bias Modification (ABM): Approach bias modification (ABM) is a novel treatment that involves retraining the implicit action tendency to approach a drug cue by manipulating contingencies in a stimulus-response paradigm. Psychosocial therapy for cannabis use disorder.: All participants will receive psychosocial therapy for cannabis use disorder. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Sherman, Ph.D. | Medical University of South Carolina | 843-792-8174 | shermanb@musc.edu |
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| 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 | Jan 18, 2023 | Oct 29, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2023 | Oct 29, 2024 | ICF_001.pdf |
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| Sham ABM | Behavioral | Sham ABM involves similar computerized procedures that mimic the active experimental condition, but do not involve manipulation of response contingencies and thus it does not contain any "active" intervention. |
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| Psychosocial therapy for cannabis use disorder. | Behavioral | All participants will receive psychosocial therapy for cannabis use disorder. |
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Cannabis craving was assessed using the Marijuana Craving Questionnaire-Short Form (MCQ-SF) a self-reporting tool with 12 items rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The 12 items are grouped by certain characteristics and the score of each of resulting groups correlates to the intensity of the four craving dimensions (compulsivity, emotionality, expectancy, and purposefulness). Scores from the four subscales are summed with total possible scores ranging from 12 - 84. Higher scores are indicative of increased craving. |
| 8 weeks |
| BG001 | Sham ABM + CBT/MET | Participants in the Sham ABM condition will undergo similar computerized tasks without the manipulation of response contingencies that target modification of approach bias. All participants will receive MET/CBT therapy. Sham ABM: Sham ABM involves similar computerized procedures that mimic the active experimental condition, but do not involve manipulation of response contingencies and thus it does not contain any "active" intervention. Psychosocial therapy for cannabis use disorder.: All participants will receive psychosocial therapy for cannabis use disorder. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Marijuana Craving Questionnaire Total Score (MCQ) | Cannabis craving was assessed using the Marijuana Craving Questionnaire-Short Form (MCQ-SF) a self-reporting tool with 12 items rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The 12 items are grouped by certain characteristics and the score of each of resulting groups correlates to the intensity of the four craving dimensions (compulsivity, emotionality, expectancy, and purposefulness). Scores from the four subscales are summed with total possible scores ranging from 12 - 84. Higher scores are indicative of increased craving. | Baseline analysis on n=98 participants that returned to have MCQ assessment on visit 1. Data are presented as baseline measures on visit 1. | Mean | Standard Deviation | units on a scale |
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| ID |
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| Title |
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| Description |
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| OG000 | Active ABM + CBT/MET | Participants in the Active ABM condition will receive approach bias modification (ABM) training sessions aimed at reducing cognitive bias for cannabis cues. All participants will receive MET/CBT therapy. Approach Bias Modification (ABM): Approach bias modification (ABM) is a novel treatment that involves retraining the implicit action tendency to approach a drug cue by manipulating contingencies in a stimulus-response paradigm. Psychosocial therapy for cannabis use disorder.: All participants will receive psychosocial therapy for cannabis use disorder. |
| OG001 | Sham ABM + CBT/MET | Participants in the Sham ABM condition will undergo similar computerized tasks without the manipulation of response contingencies that target modification of approach bias. All participants will receive MET/CBT therapy. Sham ABM: Sham ABM involves similar computerized procedures that mimic the active experimental condition, but do not involve manipulation of response contingencies and thus it does not contain any "active" intervention. Psychosocial therapy for cannabis use disorder.: All participants will receive psychosocial therapy for cannabis use disorder. |
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| Secondary | Percent Days Using Cannabis | Using self-report we will evaluate the efficacy of ABM on percent days using cannabis, measurements will be summarized at end of study treatment and at the follow up visit. | all randomized participants that returned post randomization. | Posted | Mean | Standard Deviation | Percentage of day reported using can | Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks) |
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| Secondary | Marijuana Craving Questionnaire Total Score (Craving) | Cannabis craving was assessed using the Marijuana Craving Questionnaire-Short Form (MCQ-SF) a self-reporting tool with 12 items rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The 12 items are grouped by certain characteristics and the score of each of resulting groups correlates to the intensity of the four craving dimensions (compulsivity, emotionality, expectancy, and purposefulness). Scores from the four subscales are summed with total possible scores ranging from 12 - 84. Higher scores are indicative of increased craving. | All randomized participants that have at least 1 time point of MCQ measured. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Sham ABM + CBT/MET | Participants in the Sham ABM condition will undergo similar computerized tasks without the manipulation of response contingencies that target modification of approach bias. All participants will receive MET/CBT therapy. Sham ABM: Sham ABM involves similar computerized procedures that mimic the active experimental condition, but do not involve manipulation of response contingencies and thus it does not contain any "active" intervention. Psychosocial therapy for cannabis use disorder.: All participants will receive psychosocial therapy for cannabis use disorder. | 0 | 51 | 0 | 51 | 0 | 51 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| End of Treatment (4 weeks) |
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| Follow Up (8 weeks) |
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| Baseline: MJ |
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| End of Treatment (4 weeks): Non MJ |
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| End of Treatment (4 weeks): MJ |
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| Follow up (8 weeks): Non MJ |
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| Follow Up (8 weeks): MJ |
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