Approach Bias Modification for the Treatment of Cannabis Use Disorder

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.

Study Overview

• Status: Completed
• Conditions: Cannabis Use Disorder
• Intervention / Treatment: Behavioral: Approach Bias Modification (ABM); Behavioral: Psychosocial therapy for cannabis use disorder.; Behavioral: Sham ABM

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian J Sherman, Ph.D.; Phone Number: 843-792-8174; Email: shermanb@musc.edu
• Study Contact Backup: Name: Lisa Nunn, M.A.; Phone Number: 843-792-0476; Email: jenkinli@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medial University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be age 18-65 and must be able to provide informed consent.
2. Meet DSM-5 criteria for current moderate to severe CUD (past 60 days).
3. Identify cannabis as their primary substance of choice.
4. Consent to remain abstinent from alcohol and cannabis for 12 hours immediately prior to study visits and other drugs of abuse (except nicotine) for three days prior (see Additional Instrumentation below for methods); by restricting cannabis and other substance use as proposed, participants should not be under the acute effects of cannabis or other substances.

Exclusion Criteria:

1. Evidence of, or a history of serious medical or neurological disease that may affect cognitive processing.
2. History of, or current psychotic disorder, bipolar disorder, and attention-deficit hyperactivity disorder, or current untreated major depressive disorder as these may interfere with subjective measurements.
3. Current use of psychotropic medications because these may affect subjective measurements (individuals taking antidepressants will be allowed).
4. Current suicidal ideation. Individuals who endorse suicidal ideation will be seen by a psychologist or psychiatrist in the office and will be referred to treatment as necessary.
5. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
6. Moderate to severe DSM-5 substance use disorder within the past 60 days (other than nicotine or cannabis).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Behavioral: Psychosocial therapy for cannabis use disorder.; All participants will receive psychosocial therapy for cannabis use disorder.
Sham Comparator: 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.	Behavioral: Psychosocial therapy for cannabis use disorder.; All participants will receive psychosocial therapy for cannabis use disorder.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cannabis cue-reactivity	Using a cue-reactivity paradigm, we will evaluate the efficacy of approach bias modification on physiological (i.e. skin conductance) and subjective (i.e. cannabis craving) cue-reactivity.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent days abstinent	Using self-report we will evaluate the efficacy of ABM on percent days abstinent.	8 weeks
Change in creatinine-adjusted cannabinoid levels	Using urine toxicology we will evaluate the efficacy of ABM on creatinine-adjusted cannabinoid levels.	8 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Brian J Sherman, Ph.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: Pro00077532; 5K23DA045099-05 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No