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Trial record 34 of 152 for:    Recruiting, Not yet recruiting, Available Studies | "Marijuana Abuse"

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

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.


Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Behavioral: Approach Bias Modification (ABM) Behavioral: Sham ABM Behavioral: Psychosocial therapy for cannabis use disorder. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Approach Bias Modification for the Treatment of Cannabis Use Disorder
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in percent days abstinent [ Time Frame: 8 weeks ]
    Using self-report we will evaluate the efficacy of ABM on percent days abstinent.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629990


Contacts
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Contact: Brian J Sherman, Ph.D. 843-792-8174 shermanb@musc.edu
Contact: Lisa Nunn, M.A. 843-792-0476 jenkinli@musc.edu

Locations
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United States, South Carolina
Medial University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Brian J Sherman, Ph.D.    843-792-8174    shermanb@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Brian J Sherman, Ph.D. Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03629990     History of Changes
Other Study ID Numbers: Pro00077532
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Marijuana Abuse
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders