NCT03629990

Approach Bias Modification for the Treatment of Cannabis Use Disorder

Completed NA Results posted Last updated 17 December 2024

What this trial tests

NA trial testing Approach Bias Modification (ABM) in Cannabis Use Disorder in 104 participants. Completed in 30 October 2023.

Timeline

16 January 2019

Primary endpoint
30 October 2023

30 October 2023

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	104
Start date	16 January 2019
Primary completion	30 October 2023
Estimated completion	30 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Approach Bias Modification (ABM)
• Sham ABM
• Psychosocial therapy for cannabis use disorder.

Conditions studied

• Cannabis Use Disorder — all drugs for Cannabis Use Disorder →

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 65, any sex, with Cannabis Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cannabis Approach Bias Primary · Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks)

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

Baseline: neutral

Group	Value	95% CI
Active ABM + CBT/MET	-8.43	± 57.1
Sham ABM + CBT/MET	4.05	± 46.1

Baseline: cannabis

Group	Value	95% CI
Active ABM + CBT/MET	5.43	± 56.2
Sham ABM + CBT/MET	-1.36	± 41.9

End of Treatment (4 weeks): neutral

Group	Value	95% CI
Active ABM + CBT/MET	1.8	± 43.6
Sham ABM + CBT/MET	-0.22	± 49.3

End of Treatment (4 weeks): cannabis

Group	Value	95% CI
Active ABM + CBT/MET	-16.1	± 41.9
Sham ABM + CBT/MET	-1.74	± 47.8

Follow Up (8 weeks): Neutral

Group	Value	95% CI
Active ABM + CBT/MET	2.82	± 47.8
Sham ABM + CBT/MET	-6.34	± 33.7

Follow Up (8 weeks): Cannabis

Group	Value	95% CI
Active ABM + CBT/MET	-6.76	± 29.4
Sham ABM + CBT/MET	1.66	± 24.3

Percent Days Using Cannabis Secondary · Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks)

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

Group	Value	95% CI
Active ABM + CBT/MET	86.6	± 20.2
Sham ABM + CBT/MET	87.7	± 18.9

End of Treatment (4 weeks)

Group	Value	95% CI
Active ABM + CBT/MET	74.1	± 29.1
Sham ABM + CBT/MET	72.0	± 28.4

Follow Up (8 weeks)

Group	Value	95% CI
Active ABM + CBT/MET	69.1	± 35.3
Sham ABM + CBT/MET	71.7	± 34.8

Marijuana Craving Questionnaire Total Score (Craving) Secondary · 8 weeks

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: Non MJ

Group	Value	95% CI
Active ABM + CBT/MET	39.5	± 16.1
Sham ABM + CBT/MET	38.6	± 16.2

Baseline: MJ

Group	Value	95% CI
Active ABM + CBT/MET	43.1	± 17.8
Sham ABM + CBT/MET	40.3	± 17.6

End of Treatment (4 weeks): Non MJ

Group	Value	95% CI
Active ABM + CBT/MET	31	± 15.9
Sham ABM + CBT/MET	31.1	± 15.8

End of Treatment (4 weeks): MJ

Group	Value	95% CI
Active ABM + CBT/MET	31.4	± 13.9
Sham ABM + CBT/MET	32.1	± 17.2

Follow up (8 weeks): Non MJ

Group	Value	95% CI
Active ABM + CBT/MET	28.3	± 16.9
Sham ABM + CBT/MET	25.2	± 14.5

Follow Up (8 weeks): MJ

Group	Value	95% CI
Active ABM + CBT/MET	30	± 18.5
Sham ABM + CBT/MET	26.5	± 15.1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.