Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving
Condition: Cocaine Addiction
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Intervention: Propranolol, 40 mg; Propranolol, 80 mg; Placebo
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Abuse; Cocaine; Addiction

Summary:

      The investigators' recently completed study has provided the first evidence that
      administration of the medication propranolol, following exposure to cocaine cues, can alter
      drug-associated memories and reduce craving and other drug cue-elicited responses in cocaine
      addicted persons. The investigators will attempt to augment this effect by a) doubling the
      number of propranolol-medicated cocaine cue exposure (CCE) retrieval sessions and b)
      increasing the dose of propranolol. It is expected that propranolol treated groups, relative
      to placebo treated groups, will evidence greater reduction of craving, cue reactivity and
      cocaine use during follow-up cocaine cue exposures. Also, these effects will be greater for
      those who receive 80mg of propranolol as opposed to 40mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must meet DSM-IV criteria for current cocaine dependence (within the past
             month). Participants may meet criteria for abuse, but not dependence, for any other
             substance with the exception of nicotine. Because of the high comorbidity of cocaine
             and nicotine dependence, excluding nicotine dependence would seriously compromise the
             feasibility of recruitment (nicotine patch will be provided to participants during the
             course of their involvement in the laboratory procedures). Although individuals who
             meet criteria for alcohol abuse will be accepted for study participation, anyone who
             has a measurable blood alcohol level on the day of testing will be excluded as acute
             alcohol intake can lower seizure threshold.

          -  Participants must be able to provide informed consent and function at an intellectual
             level sufficient to allow accurate completion of all assessment instruments.Exclusion
             Criteria:

          -  Use of one of the following methods of birth control by female participants: barrier
             methods (diaphragm or condoms with spermicidal or both), surgical sterilization, use
             of an intra-uterine contraceptive device, or complete abstinence from sexual
             intercourse.

          -  Individuals must live within a 50-mile radius of our research program and have
             reliable transportation.

          -  Individuals must consent to remain abstinent from all drugs of abuse (except nicotine)
             for 72 hours immediately prior to CTRC inpatient admission.

          -  Individuals must consent to random assignment to one of three study groups (the two
             propranolol-treated groups or the placebo-treated group).

        Exclusion Criteria:

          -  Women who are pregnant, nursing or of childbearing potential and not practicing an
             effective means of birth control.

          -  Individuals with evidence of or a history of significant hematological, endocrine,
             cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including
             diabetes, as these conditions may affect heart rate or skin conductance measurement.

          -  Individuals with significant liver impairment as propranolol is hepatically
             metabolized.

          -  Individuals with a history of or current psychotic disorder, current major depressive
             disorder, bipolar affective disorder or a severe anxiety disorder as these may impact
             cue reactivity.

          -  Individuals currently taking anti-arrythmic agents, psychostimulants or any other
             agents known to interfere with heart rate and skin conductance monitoring.

          -  Known or suspected hypersensitivity to propranolol.

          -  Individuals taking medications that could adversely interact with the study
             medication, including, but not limited to albuterol, insulin, or significant
             inhibitors of CYP2D6.

          -  Individuals with bronchial asthma or chronic obstructive pulmonary disease, as the use
             of propranolol is contraindicated in these individuals.

          -  Individuals with any physical condition or disability that would compromise optimal
             sensory processing of the cues (e.g., blindness).