Yohimbine to Enhance Cognitive Behavioral Therapy (CBT) for Social Anxiety
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ClinicalTrials.gov Identifier: NCT00958880 |
Recruitment Status :
Completed
First Posted : August 13, 2009
Results First Posted : November 11, 2013
Last Update Posted : November 11, 2013
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Condition or disease | Intervention/treatment | Phase |
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Social Anxiety Disorder | Behavioral: Group Cognitive Behavioral Therapy Drug: Yohimbine Hydrochloride Drug: Sugar Pill | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Placebo-Controlled Evaluation of the Efficacy of Yohimbine Hydrochloride for Enhancing the Effects of CBT for Social Phobia |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Sugar Pill
Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
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Behavioral: Group Cognitive Behavioral Therapy
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. Drug: Sugar Pill 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. |
Experimental: Yohimbine Hydrochloride
Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
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Behavioral: Group Cognitive Behavioral Therapy
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. Drug: Yohimbine Hydrochloride Participants in the Yohimbine augmented arm will receive 4 doses of Yohimbine Hydrochloride before 4 of the 5 group cognitive behavioral therapy sessions. |
- The Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: LSAS means at 1 month follow-up ]The Liebowitz Social Anxiety Scale (LSAS) is a self-report measure of social anxiety symptom severity. Scores range from 0 to 144, with higher scores indicating more social anxiety symptoms severity (i.e., a worse outcome).
- Social Phobic Disorders Severity and Change Form [ Time Frame: CGI change scores from baseline to 1 month follow-up ]Social Phobic Disorders Severity and Change (SPDSC) Form is a version of the Clinical Global Improvement-Severity scale adapted specifically for clinician ratings of social anxiety disorder symptom severity. The scale ranges from 0 to 5, with higher scores indicating more social anxiety symptoms severity (i.e., worse outcomes). We examined the change in SPDSC scores from baseline to a 1 month follow-up.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
- Severity of the social phobia of at least 3 on the CGI scale rated for the severity of public speaking anxiety
- Willingness and ability to comply with the requirements of the study protocol.
Exclusion Criteria:
- 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.
- 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.
- 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.
- 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
- 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.
- Resting blood pressure ≥ 160 systolic and/or 100 diastolic. Individuals currently being treated for high blood pressure and meeting these criteria are eligible.
- Significant personality dysfunction likely to interfere with study participation.
- Patients with a current or past history of seizures
- 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.
- 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.
- 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.
- Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
- Patients unable to understand study procedures and participate in the informed consent process.

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): NCT00958880
United States, Massachusetts | |
Boston University | |
Boston, Massachusetts, United States, 02215 | |
United States, Texas | |
Southern Methodist University | |
Dallas, Texas, United States, 75206 |
Principal Investigator: | Jasper Smits, Ph.D. | Southern Methodist University | |
Principal Investigator: | Michael W Otto, Ph.D. | Boston University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jasper Smits, Ph.D., Principal Investigator, Southern Methodist University |
ClinicalTrials.gov Identifier: | NCT00958880 |
Other Study ID Numbers: |
KS09-088 KS09-088 |
First Posted: | August 13, 2009 Key Record Dates |
Results First Posted: | November 11, 2013 |
Last Update Posted: | November 11, 2013 |
Last Verified: | September 2013 |
Anxiety Disorders Phobia, Social Mental Disorders Phobic Disorders Yohimbine Mydriatics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Adrenergic alpha-2 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Urological Agents |