Approach Bias Modification for the Treatment of Cannabis Use Disorder

NCT03629990 | Completed Results

• 2 other identifiers: Pro000775325K23DA045099-05
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Percent Days Using Cannabis

  Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks)

• Marijuana Craving Questionnaire Total Score (Craving)

  8 weeks

Study Arms (2)

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.

Behavioral: Approach Bias Modification (ABM); Behavioral: Psychosocial therapy for cannabis use disorder.

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.

Behavioral: Sham ABM; Behavioral: Psychosocial therapy for cannabis use disorder.

Interventions

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.

Active ABM + CBT/MET

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.

Sham ABM + CBT/MET

Psychosocial therapy for cannabis use disorder. BEHAVIORAL

All participants will receive psychosocial therapy for cannabis use disorder.

Active ABM + CBT/MET; Sham ABM + CBT/MET

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be age 18-65 and must be able to provide informed consent.
• Meet DSM-5 criteria for current moderate to severe CUD (past 60 days).
• Identify cannabis as their primary substance of choice.
• 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.

You may not qualify if:

• Evidence of, or a history of serious medical or neurological disease that may affect cognitive processing.
• 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.
• Current use of psychotropic medications because these may affect subjective measurements (individuals taking antidepressants will be allowed).
• 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.
• Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
• Moderate to severe DSM-5 substance use disorder within the past 60 days (other than nicotine or cannabis).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medial University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Results Point of Contact

• Title: Brian Sherman, Ph.D.
• Organization: Medical University of South Carolina

shermanb@musc.edu

843-792-8174

Study Officials

• Brian J Sherman, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: August 14, 2018
• Study Start: January 16, 2019
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: December 17, 2024
• Results First Posted: December 17, 2024

Record last verified: 2024-11

Locations

US (1)