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Lupron Sex Offender Therapy

NCT00220350 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2005-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Pedophilia

Interventions

DRUG

leuprolide acetate

Sponsors & Collaborators

  • TAP Pharmaceutical Products Inc.

    collaborator INDUSTRY

  • Schober, Justine, M.D.

    lead INDIV

Principal Investigators

  • Justine M Schober, MD · Hamot Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-10-31
Completion
2005-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00220350 on ClinicalTrials.gov