Lupron Sex Offender Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Schober, Justine, M.D..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by:
Schober, Justine, M.D.
ClinicalTrials.gov Identifier:
NCT00220350
First received: September 16, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

This study compared cognitive-behavioral psychotherapy with leuprolide acetate (LA) to cognitive-behavioral psychotherapy with saline injections for 12 months. Five white male pedophiles (M age, 50 years; range, 36-58) volunteered for a two-year study. LA was administered by Depo injection (7 mg initially, then 22.5 mg every 3 mos) for 12 months, followed by saline placebo. Effects of LA on testosterone levels, sexual interest preference by visual reaction time (Abel Assessment), penile tumescence (Monarch PPG), as well strong urges and masturbatory frequency to children (polygraph), were measured every three months. Subjects were treated with weekly cognitive-behavioral psychotherapy. On LA, testosterone decreased to castrate levels. Because of the suppression of testosterone, physiologic arousal response as measured by penile plethysmography (penile tumescence) was significantly suppressed compared with baseline. However, sufficient response remained to detect pedophilic interest. This pedophilic interest was also detected by visual reaction times. All subjects self-reported a decrease in strong pedophilic urges and masturbation. When asked about having pedophilic urges and masturbating to thoughts of children, polygraph responses indicated subjects were not deceptive when they reported decreases. On placebo, testosterone and physiologic arousal eventually rose to baseline levels. At baseline and on placebo, subjects were consistently deceptive regarding increased pedophilic urges and masturbatory frequency as noted by polygraph. Interest preference, as measured by Abel Assessment and Monarch PPG, was generally unchanged throughout the study. Cognitive-behavioral psychotherapy augmented with LA significantly reduced pedophilic fantasies, urges, and masturbation, but did not change pedophilic interest during one year of therapy. Deceptive responses by polygraph suggested that self-report was unreliable. Follow-up utilizing objective measures is essential for monitoring efficacy of treatment in pedophilia. Our study supports the supposition that modification of pedophilic behavior is possible. LA may augment cognitive-behavioral psychotherapy and help break the sequence leading to a reoffense.


Condition Intervention Phase
Pedophilia
Drug: leuprolide acetate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Leuprolide Acetate Suppresses Pedophilic Urges and Arousability

Resource links provided by NLM:


Further study details as provided by Schober, Justine, M.D.:

Primary Outcome Measures:
  • suppressed arousal

Secondary Outcome Measures:
  • safety

Estimated Enrollment: 10
Study Start Date: October 2001
Estimated Study Completion Date: August 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:pedohilia admission,healthy,male,adult,ability to have penile response on plethysmography -

Exclusion Criteria:Denial of pedophilia, seizure disorder treated with dilantin or barbiturates, alcoholism, IQ less than 70

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00220350

Locations
United States, Pennsylvania
Hamot Medical Center
Erie, Pennsylvania, United States, 16507
Sponsors and Collaborators
Schober, Justine, M.D.
TAP Pharmaceutical Products Inc.
Investigators
Principal Investigator: Justine M Schober, MD Hamot Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00220350     History of Changes
Other Study ID Numbers: Lupron trial, TAP Pharmaceuticals
Study First Received: September 16, 2005
Last Updated: September 16, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Schober, Justine, M.D.:
arousal
sex offender
suppression of arousal
pedohilia
leuprolide acetate

Additional relevant MeSH terms:
Pedophilia
Paraphilias
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014