Trial Outcomes & Findings for Approach Bias Modification for the Treatment of Cannabis Use Disorder (NCT NCT03629990)
NCT ID: NCT03629990
Last Updated: 2024-12-17
Results Overview
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
COMPLETED
NA
104 participants
Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks)
2024-12-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
27
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline analysis on n=98 participants that returned to have MCQ assessment on visit 1. Data are presented as baseline measures on visit 1.
Baseline characteristics by cohort
| Measure |
Active ABM + CBT/MET
n=53 Participants
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.
|
Sham ABM + CBT/MET
n=51 Participants
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.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=53 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=104 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=53 Participants
|
50 Participants
n=51 Participants
|
102 Participants
n=104 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=53 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=104 Participants
|
|
Age, Continuous
|
33.6 years
STANDARD_DEVIATION 11.7 • n=53 Participants
|
31.1 years
STANDARD_DEVIATION 10 • n=51 Participants
|
32.4 years
STANDARD_DEVIATION 10.9 • n=104 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=53 Participants
|
23 Participants
n=51 Participants
|
47 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=53 Participants
|
28 Participants
n=51 Participants
|
57 Participants
n=104 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=53 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=53 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=53 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=53 Participants
|
15 Participants
n=51 Participants
|
28 Participants
n=104 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=53 Participants
|
33 Participants
n=51 Participants
|
70 Participants
n=104 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=53 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=53 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=104 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=53 Participants
|
51 participants
n=51 Participants
|
104 participants
n=104 Participants
|
|
Marijuana Craving Questionnaire Total Score (MCQ)
|
42.5 units on a scale
STANDARD_DEVIATION 16.0 • n=50 Participants • Baseline analysis on n=98 participants that returned to have MCQ assessment on visit 1. Data are presented as baseline measures on visit 1.
|
41.9 units on a scale
STANDARD_DEVIATION 14.5 • n=48 Participants • Baseline analysis on n=98 participants that returned to have MCQ assessment on visit 1. Data are presented as baseline measures on visit 1.
|
42.2 units on a scale
STANDARD_DEVIATION 15.2 • n=98 Participants • Baseline analysis on n=98 participants that returned to have MCQ assessment on visit 1. Data are presented as baseline measures on visit 1.
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks)Population: All randomized participants with at least one post randomization visit.
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
Outcome measures
| Measure |
Active ABM + CBT/MET
n=50 Participants
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.
|
Sham ABM + CBT/MET
n=48 Participants
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.
|
|---|---|---|
|
Cannabis Approach Bias
Baseline: neutral
|
-8.43 seconds
Standard Deviation 57.1
|
4.05 seconds
Standard Deviation 46.1
|
|
Cannabis Approach Bias
Baseline: cannabis
|
5.43 seconds
Standard Deviation 56.2
|
-1.36 seconds
Standard Deviation 41.9
|
|
Cannabis Approach Bias
End of Treatment (4 weeks): neutral
|
1.8 seconds
Standard Deviation 43.6
|
-0.22 seconds
Standard Deviation 49.3
|
|
Cannabis Approach Bias
End of Treatment (4 weeks): cannabis
|
-16.1 seconds
Standard Deviation 41.9
|
-1.74 seconds
Standard Deviation 47.8
|
|
Cannabis Approach Bias
Follow Up (8 weeks): Neutral
|
2.82 seconds
Standard Deviation 47.8
|
-6.34 seconds
Standard Deviation 33.7
|
|
Cannabis Approach Bias
Follow Up (8 weeks): Cannabis
|
-6.76 seconds
Standard Deviation 29.4
|
1.66 seconds
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks)Population: all randomized participants that returned post randomization.
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.
Outcome measures
| Measure |
Active ABM + CBT/MET
n=50 Participants
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.
|
Sham ABM + CBT/MET
n=48 Participants
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.
|
|---|---|---|
|
Percent Days Using Cannabis
End of Treatment (4 weeks)
|
74.1 Percentage of day reported using can
Standard Deviation 29.1
|
72.0 Percentage of day reported using can
Standard Deviation 28.4
|
|
Percent Days Using Cannabis
Follow Up (8 weeks)
|
69.1 Percentage of day reported using can
Standard Deviation 35.3
|
71.7 Percentage of day reported using can
Standard Deviation 34.8
|
|
Percent Days Using Cannabis
Baseline
|
86.6 Percentage of day reported using can
Standard Deviation 20.2
|
87.7 Percentage of day reported using can
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomized participants that have at least 1 time point of MCQ measured.
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.
Outcome measures
| Measure |
Active ABM + CBT/MET
n=50 Participants
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.
|
Sham ABM + CBT/MET
n=48 Participants
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.
|
|---|---|---|
|
Marijuana Craving Questionnaire Total Score (Craving)
Baseline: Non MJ
|
39.5 units on a scale
Standard Deviation 16.1
|
38.6 units on a scale
Standard Deviation 16.2
|
|
Marijuana Craving Questionnaire Total Score (Craving)
Baseline: MJ
|
43.1 units on a scale
Standard Deviation 17.8
|
40.3 units on a scale
Standard Deviation 17.6
|
|
Marijuana Craving Questionnaire Total Score (Craving)
End of Treatment (4 weeks): Non MJ
|
31 units on a scale
Standard Deviation 15.9
|
31.1 units on a scale
Standard Deviation 15.8
|
|
Marijuana Craving Questionnaire Total Score (Craving)
End of Treatment (4 weeks): MJ
|
31.4 units on a scale
Standard Deviation 13.9
|
32.1 units on a scale
Standard Deviation 17.2
|
|
Marijuana Craving Questionnaire Total Score (Craving)
Follow up (8 weeks): Non MJ
|
28.3 units on a scale
Standard Deviation 16.9
|
25.2 units on a scale
Standard Deviation 14.5
|
|
Marijuana Craving Questionnaire Total Score (Craving)
Follow Up (8 weeks): MJ
|
30 units on a scale
Standard Deviation 18.5
|
26.5 units on a scale
Standard Deviation 15.1
|
Adverse Events
Active ABM + CBT/MET
Sham ABM + CBT/MET
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Sherman, Ph.D.
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place