Approach Bias Modification for the Treatment of Cannabis Use Disorder
NCT ID: NCT03629990
Last Updated: 2024-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2019-01-16
2023-10-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Medical University of South Carolina
OTHER
Responsible Party
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Principal Investigators
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Brian J Sherman, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medial University of South Carolina
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00077532
Identifier Type: -
Identifier Source: org_study_id