Yohimbine to Enhance Cognitive Behavioral Therapy (CBT) for Social Anxiety
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: Group Cognitive Behavioral Therapy; Yohimbine Hydrochloride; Sugar Pill
Intervention description: 5 weeks of group CBT for Social Anxiety. The aim of CBT is to help participants become more comfortable with social situations
One arm will receive placebo augmented Group Cognitive Behavioral Therapy and the other will receive yohimbine hydrochloride augmented cognitive behavioral therapy.; Participants in the Yohimbine augmented arm will receive 4 doses of Yohimbine Hydrochloride before 4 of the 5 group cognitive behavioral therapy sessions.; Participants in the placebo (sugar pill) augmented arm will receive 4 doses of a sugar pill before 4 of the 5 group cognitive behavioral therapy sessions.
Intervention MeSH terms: Yohimbine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the utility of Yohimbine hydrochloride for
      facilitating fear extinction in a sample of patients with social phobia who will be treated
      with CBT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female outpatients between 18 and 65 years of age with a primary psychiatric
             diagnosis (designated by the patient as the most important source of current distress)
             of non-generalized social anxiety disorder (SAD) or Generalized Social Anxiety
             Disorder (GSAD) with a significant fear of public speaking as defined by DSM-IV
             criteria.

          2. Severity of the social phobia of at least 3 on the CGI scale rated for the severity of
             public speaking anxiety

          3. Willingness and ability to comply with the requirements of the study protocol.

        Exclusion Criteria:

          1. A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders
             or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic
             brain syndrome, mental retardation or other cognitive dysfunction that could interfere
             with capacity to engage in therapy; a history of substance (amphetamines,
             benzodiazepines, barbiturates, cocaine metabolites, marijuana, narcotics, and sedative
             hypnotics) abuse or dependence or alcohol abuse or dependence (other than nicotine) in
             the last 6 months or otherwise unable to commit to refraining from alcohol use during
             the acute period of study participation.

          2. Patients with posttraumatic stress disorder within the past 6 months are excluded.
             Entry of patients with other mood or anxiety disorders will be permitted if the social
             anxiety disorder is judged to be the predominant disorder, in order to increase
             accrual of a clinically relevant sample. Patients with significant suicidal ideation
             (BDI item 9 score > 1) or who have enacted suicidal behaviors within 6 months prior to
             intake will be excluded from study participation and referred for appropriate clinical
             intervention.

          3. Given that Yohimbine hydrochloride is frequently used as an adjunctive medication in
             order to decrease side effects commonly resulting from antidepressant use (Pollack &
             Smoller, 1996), antidepressant and anxiolytic medications are acceptable if they are
             stabilized for at least 8 weeks prior to the baseline assessments. However,
             individuals taking monoamine oxidase inhibitors or tricyclic antidepressants will be
             excluded from the study unless they are able and willing to discontinue these
             medications prior to baseline screening.

          4. Individuals taking antihistamines or strattera (atomoxetine) will be excluded from the
             study unless they are able and willing to discontinue these medications prior to
             baseline screening

          5. Evidence through interview or physical exam of significant general medical condition
             (e.g renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic
             or cerebrovascular disease, or malignancy) that may interfere with the interpretation
             of safety and efficacy evaluations in the opinion of the prescribing physician.

          6. Resting blood pressure ≥ 160 systolic and/or 100 diastolic. Individuals currently
             being treated for high blood pressure and meeting these criteria are eligible.

          7. Significant personality dysfunction likely to interfere with study participation.

          8. Patients with a current or past history of seizures

          9. Pregnant women, lactating women, and women of childbearing potential who are not using
             medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier
             devices, condoms and foam, or implanted progesterone rods stabilized for at least 3
             months). A urine pregnancy test will be performed on all female subjects of
             child-bearing potential at the screening visit.

         10. Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing
             psychotherapy of any duration directed specifically toward treatment of the SAD is
             excluded. Prohibited psychotherapy includes CBT or psychodynamic therapy focusing on
             exploring specific, dynamic causes of the phobic symptomatology and provides
             management skills. General supportive therapy initiated > 3 months prior is
             acceptable.

         11. Prior non-response to adequately-delivered exposure (i.e., as defined by the patient's
             report of receiving specific and regular exposure assignments as part of a previous
             treatment) will exclude participants from the study.

         12. Patients with a history of head trauma causing loss of consciousness, seizure or
             ongoing cognitive impairment.

         13. Patients unable to understand study procedures and participate in the informed consent
             process.