D-Cycloserine-Enhancer of One-Session Treatment for Phobia of Heights
Status: | Completed |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/2/2016 |
Start Date: | July 2009 |
End Date: | December 2014 |
D-Cycloserine as Enhancer of One-Session Treatment for Phobia of Heights in Adults
The study will determine the effects of D-Cycloserine (DCS) on fear reduction in patients
diagnosed with phobia of heights (acrophobia) undergoing one session of three hours of
virtual reality exposure therapy (VRET) or in vivo exposure therapy (IVET).
diagnosed with phobia of heights (acrophobia) undergoing one session of three hours of
virtual reality exposure therapy (VRET) or in vivo exposure therapy (IVET).
The impact of D-Cycloserine on Virtual Reality Exposure Therapy (VRET) and In Vivo Exposure
Therapy (IVET) for phobia of heights (acrophobia) will be tested using a randomized,
double-blind, placebo-controlled trial. Eighty participants will be randomly assigned to one
of the four treatment conditions: one-session VRET (3 hours) and 50 mg D-Cycloserine (VR-OST
+ DCS, N1=20); one-session VRET (3 hours) and placebo (VR-OST + Pl, N2=20); one-session IVET
(3 hours) and placebo (IV + Pl, N3=20); or one-session IVET (3 hours) and 50 mg
D-Cycloserine, (IV + DCS, N4=20). For twenty participants (5 from each group) the treatment
will be delayed for three weeks and an additional assessment will be conducted as they will
comprise a Wait List (WL) control group. Behavioral, cognitive and physiological changes in
acrophobia will be assessed at pre-treatment, post-waitlist, post-treatment and 3 months
follow-up.
Therapy (IVET) for phobia of heights (acrophobia) will be tested using a randomized,
double-blind, placebo-controlled trial. Eighty participants will be randomly assigned to one
of the four treatment conditions: one-session VRET (3 hours) and 50 mg D-Cycloserine (VR-OST
+ DCS, N1=20); one-session VRET (3 hours) and placebo (VR-OST + Pl, N2=20); one-session IVET
(3 hours) and placebo (IV + Pl, N3=20); or one-session IVET (3 hours) and 50 mg
D-Cycloserine, (IV + DCS, N4=20). For twenty participants (5 from each group) the treatment
will be delayed for three weeks and an additional assessment will be conducted as they will
comprise a Wait List (WL) control group. Behavioral, cognitive and physiological changes in
acrophobia will be assessed at pre-treatment, post-waitlist, post-treatment and 3 months
follow-up.
Inclusion Criteria:
- Age between 18 and 65 years
- Men and women
- Diagnosis of acrophobia based on a clinical interview (ADIS-IV)
- Must sign an informed consent document after complete explanation of the study
documenting that they understand the purpose of the study, procedures to be
undertaken, possible benefits, potential risks, and are willing to participate.
Exclusion Criteria:
- A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional
disorders; organic brain syndrome, cognitive dysfunction that could interfere with
capacity to engage in therapy;
- A history of substance or alcohol dependence (other than nicotine) in the last 6
months or otherwise unable to commit to refraining from alcohol use during the period
of study participation.
- Patients with significant suicidal ideation or who have enacted suicidal behaviors
within 6 months prior to intake will be excluded from study participation and
referred for appropriate services.
- Patients must be off concurrent anxiolytics and beta blockers and on a stable dose of
antidepressant medication for at least 3 weeks prior to initiation of randomized
treatment.
- Patients receiving medication that might interfere with study medication (medication
that might lower seizure threshold: meperidine or antibiotics in high dosage:
penicillins, cephalosporins, amphotericin and imipenem),
- Patients with a current or past history of seizures
- Pregnant women, lactating women, and women of childbearing potential who are not
using medically accepted effective methods of contraception or abstinence
- Patients with a history of renal insufficiency (creatinine clearance less than 60
mL/min) or liver insufficiency
- Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing
psychotherapy of any duration specifically targeting phobias
- Patients unable to understand study procedures and participate in the informed
consent process.
- Other serious medical illnesses (e.g., cardiovascular, liver, kidney, respiratory,
endocrine, neurologic, or blood-related diseases),
- Inability to tolerate wearing the Virtual Reality Head Mounted Display,
- If patients refuse the study medication
- Any allergic reactions to D-Cycloserine by history
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