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Approach Bias Modification for the Treatment of Cannabis Use Disorder

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ClinicalTrials.gov Identifier: NCT03629990
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE May 16, 2018
First Posted Date  ICMJE August 14, 2018
Last Update Posted Date November 8, 2018
Actual Study Start Date  ICMJE November 5, 2018
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
Change in cannabis cue-reactivity [ Time Frame: 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03629990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • Change in percent days abstinent [ Time Frame: 8 weeks ]
    Using self-report we will evaluate the efficacy of ABM on percent days abstinent.
  • Change in creatinine-adjusted cannabinoid levels [ Time Frame: 8 weeks ]
    Using urine toxicology we will evaluate the efficacy of ABM on creatinine-adjusted cannabinoid levels.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Approach Bias Modification for the Treatment of Cannabis Use Disorder
Official Title  ICMJE Approach Bias Modification for the Treatment of Cannabis Use Disorder
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 four weekly MET/CBT therapy sessions. Primary outcomes will include cannabis cue-reactivity and cannabis use.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cannabis Use Disorder
Intervention  ICMJE
  • 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: 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.
  • Behavioral: Psychosocial therapy for cannabis use disorder.
    All participants will receive psychosocial therapy for cannabis use disorder.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Behavioral: Approach Bias Modification (ABM)
    • Behavioral: 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.

    Interventions:
    • Behavioral: Sham ABM
    • Behavioral: Psychosocial therapy for cannabis use disorder.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brian J Sherman, Ph.D. 843-792-8174 shermanb@musc.edu
Contact: Lisa Nunn, M.A. 843-792-0476 jenkinli@musc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03629990
Other Study ID Numbers  ICMJE Pro00077532
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian J Sherman, Ph.D. Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP