Clinical trial NCT03629990: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-08-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Cannabis Approach Bias
timeFrame: Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks)
Secondary outcomes:
measure: Percent Days Using Cannabis
timeFrame: Baseline, End of Treatment (4 weeks), Follow-Up (8 weeks)
measure: Marijuana Craving Questionnaire Total Score (Craving)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medial University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Brian J Sherman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: