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Approach Bias Modification for the Treatment of Cannabis Use Disorder

Primary Purpose

Cannabis Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Approach Bias Modification (ABM)
Sham ABM
Psychosocial therapy for cannabis use disorder.
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Medial University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active ABM + CBT/MET

Sham ABM + CBT/MET

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in percent days abstinent
Using self-report we will evaluate the efficacy of ABM on percent days abstinent.
Change in creatinine-adjusted cannabinoid levels
Using urine toxicology we will evaluate the efficacy of ABM on creatinine-adjusted cannabinoid levels.

Full Information

First Posted
May 16, 2018
Last Updated
October 24, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03629990
Brief Title
Approach Bias Modification for the Treatment of Cannabis Use Disorder
Official Title
Approach Bias Modification for the Treatment of Cannabis Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active ABM + CBT/MET
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham ABM + CBT/MET
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Approach Bias Modification (ABM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham ABM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial therapy for cannabis use disorder.
Intervention Description
All participants will receive psychosocial therapy for cannabis use disorder.
Primary Outcome Measure Information:
Title
Change in cannabis cue-reactivity
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in percent days abstinent
Description
Using self-report we will evaluate the efficacy of ABM on percent days abstinent.
Time Frame
8 weeks
Title
Change in creatinine-adjusted cannabinoid levels
Description
Using urine toxicology we will evaluate the efficacy of ABM on creatinine-adjusted cannabinoid levels.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Sherman, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medial University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Approach Bias Modification for the Treatment of Cannabis Use Disorder

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