Oxytocin and Cognitive Behavioral Therapy in Drug Dependence

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Drug Dependence

In brief

Background: \- The therapeutic alliance between therapist and patient may contribute to favorable outcomes in all types of psychotherapy, including cognitive behavioral therapy (CBT) for drug dependence. Oxytocin, a hormone and neurotransmitter, has been shown to increase trust in other people and may reduce stress and improve comfort in social situations by decreasing the sensation of social anxiety. Researchers are interested in determining if oxytocin can improve the outcomes of therapy for drug dependence by strengthening perceived levels of trust between therapist and patient. Objectives: \- To determine whether oxytocin enhances the therapeutic alliance and treatment retention for CBT for drug use. Eligibility: \- Individuals between 18 and 65 years of age who are healthy volunteers with no history of drug abuse, participants in outpatient or inpatient treatment programs for cocaine use, methadone-dependent participants in a treatment program, or non-treatment-seeking cocaine users. Design: * Participants in each treatment arm who comply with the study requirements will be randomly assigned to receive one dose of oxytocin or placebo approximately 1 hour before each weekly CBT session. * The outpatient treatment intervention will be 12 weeks of weekly individual CBT. The inpatient treatment intervention will be 6 weeks of twice-weekly individual CBT sessions. Sessions will be audiotaped. Participants and counselors will be told that the sessions are to be taped. * During treatment, participants will provide urine and breath samples under staff observation. Participants will also complete questionnaires about mood and mental health, provide other samples as required, and participate in computerized psychological testing as directed by researchers.

Key facts

Study ID

NCT00975416

Run by

National Institute on Drug Abuse (NIDA)

People needed

63

Starts

2008-11-01

Expected to finish

2013-04-01

Last updated by the study team

2015-11-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Participants will be excluded if they have evidence of:
• Schizophrenia or any other DSM-IV psychotic disorder; history of bipolar disorder; current major depressive disorder.
• Current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by DSM-IV criteria), except for inpatient cocaine arm.
• Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires.
• Renal insufficiency with serum creatinine greater than 1.7.
• Medical illness that in the view of the investigators would compromise participation in research such as: a history of syncope, family history of sudden death, electrolyte imbalance, bradycardia, arrhythmias, marked sustained high BP with SBP > 160 and or DBP > 100 on more than two readings without 3rd reading being below these parameters and not stabilized on antihypertension medications before the starting the study, congestive heart failure, history or finding on screening EKG of significant abnormality such as prolonged QTc (> 450ms) , or AIDS or HIV positive with T cell count less than or equal to 200.
• Urologic conditions that would inhibit urine collection.
• Untreated Endocrine disorders.
• Pregnancy, planning to become pregnant, or breastfeeding. In addition, women of child-bearing age who are sexually active are required to use an effective form of birth control for the duration of the study. Effective forms of birth control include:
• hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones),
• surgical sterility (tubal ligation or hysterectomy)
• IUD
• Diaphragm with spermicide
• Condom with spermicide
• For the methadone arm, use of any drugs that would interact with methadone to produce adverse effects such as Class I or Class III antiarrhythmics, TCA s, MAOI s, calcium channel blockers, neuroleptics or frequent use of sedative hypnotic drugs. Justification: Avoidance of adverse interaction with methadone. Assessment tool(s): Clinical interview and tox screen.
• Use of any drugs (prostaglandins, vasoconstricting agents or anesthetic medications, for example) that may interact with oxytocin. Justification: Avoidance of adverse interaction with oxytocin. Assessment tool(s): Clinical interview and tox screen
• History of hypersensitivity to oxytocin or vehicle, i.e. propylparahydroxybenzioate, methylparahydroxybenziate, chlorbutanol hemihydrate. Assessment tool: clinical interview
• Presence of or history of clinically significant allergic rhinitis as assessed by MRP or PI. Justification: Inflammation of nasal mucosa could interfere with mucosal absorption of intranasally administered OT.
• In addition, participants will be excluded from fMRI scanning if they:
• Are not suitable for fMRI due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology, or claustrophobia. Justification: MR scanning is the primary measurement tool used in this portion of the protocol. Assessment tool(s): Prospective participants will fill out an MRI screening questionnaire and undergo an interview with an MR technologist. Pregnancy tests will be performed on all female participants of childbearing age before each experimental session. Questions concerning suitability for scanning will be referred to the MR Medical Safety Officer. Prospective participants will be questioned about symptoms of claustrophobia and placed in the mock scanner during their screening visit to assess for possible difficulty tolerating the confinement of the scanner and for ability to physically fit into the scanner.
• Have coagulopathies, history of or current superficial or deep vein thrombosis, or musculoskeletal abnormalities restricting ability to lie flat for extended periods. Justification: MR scanning sessions require participants to lie flat on their backs and remain perfectly still for approximately two hours. Therefore, conditions that would make that difficult (e.g. chronic back pain, significant scoliosis) or dangerous (e.g. familial hypercoagulability syndrome, history of thrombosis) will be exclusionary. Assessment tool(s): History and physical examination by a qualified IRP clinician, supplemented with a trial of lying in the mock scanner to assess comfort issues.
• Have HIV or syphilis. Justification: HIV and syphilis can both have CNS sequelae, thus introducing unnecessary variability into the data. Assessment tool(s): HIV blood test, syphilis serology (positive FTA).
• Have any neurological illnesses. This includes, but is not limited to, seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, or CNS tumor. Justification: CNS diseases alter CNS function and, possibly, the neuronal-vascular coupling that forms the basis of the BOLD fMRI signal to be used in this study. Assessment tool(s): History and physical examination by a qualified IRP clinician, urine drug screening for anticonvulsants not disclosed by history. History of head trauma with loss of consciousness of more than 5 minutes or with postconcussive sequelae lasting more than two days, regardless of loss of consciousness, will be exclusionary.
• Regularly use any prescription, over-the-counter, or herbal medication that may alter CNS function, cardiovascular function, or neuronal-vascular coupling. Justification: Compounds that alter BOLD signal will alter the primary measure used in the study. Assessment tool(s): History and comprehensive urine drug screening to detect use of antidepressants, benzodiazepines, antipsychotics, anticonvulsants, barbiturates, and other common medications and drugs of abuse.
• All participants who are fullfill criteria for fMRI scanning will be asked to undergo scanning; we anticipate that approximately 50 percent of enrolled participants will be scanned.

Where it is running

• National Institute on Drug Abuse — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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