Drug DependencePhase 4NCT00975416
Oxytocin and Cognitive Behavioral Therapy in Drug Dependence
A Phase 4 study testing Cognitive Behavioral Therapy and Intranasal Oxytocin in people with Drug Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Dependence
- What is being tested?
- Cognitive Behavioral Therapy and Intranasal Oxytocin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Apr 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants must:
- Be between age 18 and 65.
- Methadone arm only: opiate dependence for the past year determined by clinical exam, opiate-positive urine during screening and diagnosis confirmed by SCID.
- Cocaine outpatient arm: cocaine dependence determined by clinical exam, cocaine-positive urine during screening and diagnosis confirmed by SCID.
- Cocaine inpatient arm: Cocaine dependence determined by clinical exam during screening and diagnosis confirmed by SCID.
- Control participants: cocaine dependent and non-drug using, will be recruited to provide appropriate matches for subjects in the two treatment arms with respect to the following characteristics: age, gender, IQ, socioeconomic factors, and years of education.
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- Be free of dependence on other substances except nicotine, heroin (for the methadone arm only), or cocaine at the time of participation. Justification: Dependence on other substance may result in unique CNS deficits that would confound our results. Nicotine dependence will be allowed because nicotine use is not associated with a drug high in normal usage and the prevalence of nicotine dependence in cocaine users may make it impractical to exclude nicotine users. While it might be preferable to exclude individuals whose use of other substances reaches the threshold of abuse, inclusion of such individuals will not necessarily contaminate the data. Inpatient cocaine arm subjects who meet DSM-IV TR criteria for the course specifier In a Controlled Environment may have a history of dependence on substances other than cocaine before their admission to the inpatient treatment program. Assessment tool(s): SCID with confirmation by negative urine drug screen.
- For participation in the scanning portion of the study, participants must also:
- Be between the ages of 18-55. Justification: Many of the cognitive processes under study change with age. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age. Individuals over 55 will therefore be excluded. Assessment tool(s): driver s license, birth certificate, or other government-issued form of identification.
- Be in good health. Justification: Many illnesses can alter fMRI signal and alter cognition. Assessment tool(s): Participants will provide a brief health history during phone screening, and undergo a history and physical examination with a qualified IRP clinician (exam details discussed below in reference to specific exclusion criteria).
- Be right-handed. Justification: Many of the brain functions to be assessed in this protocol have shown some evidence of being lateralized in the brain. In order to reduce variability in the data, participants must be right-handed. Assessment tool(s): Edinburgh Handedness Inventory.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
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.
Read more
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.
Read the detailed description
Objective The therapeutic alliance (TA), a working relationship between therapist and patient, may contribute to favorable outcomes in all types of psychotherapy, including cognitive-behavioral therapy (CBT) for drug dependence. Enhancement of the TA may be possible through intranasal administration of the hormone and neurotransmitter oxytocin, which is associated with social bonding and trust. The objective of this study is to determine whether addition of intranasal oxytocin to a course of CBT for drug dependence enhances TA and treatment retention and reduces drug use post-treatment. The study will assess changes in performance on tasks that probe decision-making, emotional processing, and drug-cue reactivity. We will employ fMRI on a subset of participants to study the neural correlates of these processes.
Study population. The treatment portion of the study will be conducted in three parallel arms, not intended to be statistically compared to each other: (1) Outpatient Methadone arm (physically dependent heroin users, n = 80 evaluable); (2) Outpatient Cocaine arm (cocaine-dependent individuals, non-opiate-dependent, n = 80 evaluable); 3) Inpatient Cocaine arm (cocaine-dependent individuals, non-opiate-dependent, n = 80 evaluable). There will also be two groups of non-treatment-seeking controls (20 cocaine-using, 20 non-drug-using) to rule out practice effects on tasks; controls will not receive oxytocin or CBT.
Experimental design and methods. Primary outcome measures will be TA in all arms and drug use for methadone and cocaine outpatient arms. (1) Methadone arm: after a 5-week baseline for stabilization on methadone, participants will undergo 12 weeks of CBT, with random assignment to oxytocin (24 IU, administered before each session) or placebo. (2 and 3) Cocaine arms, inpatient and outpatient: after a 1-week baseline for assessment of drug use, participants will undergo 6 and 12 weeks respectively of CBT, with random assignment to oxytocin (24 IU, administered before each session) or placebo.
Outcome measures: Principle outcome measures for the outpatient arms will be TA measured at several points during CBT, treatment retention, and attendance at CBT sessions. Secondary outcome measures are drug use during treatment and at follow-up, drug craving during treatment and at follow-up, stress reduction during treatment and at follow-up, HIV risk behaviors during treatment and at follow-up, behavioral performance on various tasks, and neural response to these tasks for the imaging subgroup. The outcome measures for the inpatient arm will be the same as for the outpatient arms with the exception of drug use during treatment.
- Conditions
- Drug Dependence
- Being tested
- Cognitive Behavioral Therapy, Intranasal Oxytocin, Placebo
- Keywords
- Drug Dependence, Cognitive Behavior, Oxytocin, Cocaine, Heroin, fMRI
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Intranasal oxytocin given in the context of cognitive behavioral therapy
Intranasal OxytocinDrug
Intranasal oxytocin given in the context of cognitive behavioral therapy
PlaceboDrug
Placebo given in the context of cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Placebo comparator | Intranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients Receives: Behavioral: Cognitive Behavioral Therapy; Drug: Intranasal Oxytocin; Drug: Placebo |
| Outpatient Cocaine | Placebo comparator | Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients Receives: Behavioral: Cognitive Behavioral Therapy; Drug: Intranasal Oxytocin; Drug: Placebo |
| Inpatient Cocaine | Placebo comparator | Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Receives: Behavioral: Cognitive Behavioral Therapy; Drug: Intranasal Oxytocin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Alliance
Penn Helping Alliance Questionnaire containing 19 questions with possible scores from 19(low therapeutic alliance)-114(high therapeutic alliance).
Working Alliance Inventory containing 36 questions with possible scores from 36(low therapeutic alliance)-252 (high therapeutic alliance).
Measured: Post 12 weeks treatment with cognitive behavioral therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Drug DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary R Lee, M.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975416
- Sponsor's protocol ID
- 999908432
- Other IDs
- 08-DA-N432
- Status last verified
- Oct 2015
- First submitted
- 10 Sep 2009
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Aharon I, Etcoff N, Ariely D, Chabris CF, O'Connor E, Breiter HC. Beautiful faces have variable reward value: fMRI and behavioral evidence. Neuron. 2001 Nov 8;32(3):537-51. doi: 10.1016/s0896-6273(01)00491-3.
PubMed 11709163Amico JA, Mantella RC, Vollmer RR, Li X. Anxiety and stress responses in female oxytocin deficient mice. J Neuroendocrinol. 2004 Apr;16(4):319-24. doi: 10.1111/j.0953-8194.2004.01161.x.
PubMed 15089969Anderson-Hunt M, Dennerstein L. Increased female sexual response after oxytocin. BMJ. 1994 Oct 8;309(6959):929. doi: 10.1136/bmj.309.6959.929. No abstract available.
PubMed 7950665
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin and Cognitive Behavioral Therapy in Drug Dependence
- ClinicalTrials.gov ID
- NCT00975416
- Acronym / sponsor ID
- 999908432
- Conditions
- Drug Dependence
- Keywords
- Drug Dependence, Cognitive Behavior, Oxytocin, Cocaine, Heroin, fMRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 63 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Nov 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Posted 20 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective The therapeutic alliance (TA), a working relationship between therapist and patient, may contribute to favorable outcomes in all types of psychotherapy, including cognitive-behavioral therapy (CBT) for drug dependence. Enhancement of the TA may be possible through intranasal administration of the hormone and neurotransmitter oxytocin, which is associated with social bonding and trust. The objective of this study is to determine whether addition of intranasal oxytocin to a course of CBT for drug dependence enhances TA and treatment retention and reduces drug use post-treatment. The study will assess changes in performance on tasks that probe decision-making, emotional processing, and drug-cue reactivity. We will employ fMRI on a subset of participants to study the neural correlates of these processes.
Study population. The treatment portion of the study will be conducted in three parallel arms, not intended to be statistically compared to each other: (1) Outpatient Methadone arm (physically dependent heroin users, n = 80 evaluable); (2) Outpatient Cocaine arm (cocaine-dependent individuals, non-opiate-dependent, n = 80 evaluable); 3) Inpatient Cocaine arm (cocaine-dependent individuals, non-opiate-dependent, n = 80 evaluable). There will also be two groups of non-treatment-seeking controls (20 cocaine-using, 20 non-drug-using) to rule out practice effects on tasks; controls will not receive oxytocin or CBT.
Experimental design and methods. Primary outcome measures will be TA in all arms and drug use for methadone and cocaine outpatient arms. (1) Methadone arm: after a 5-week baseline for stabilization on methadone, participants will undergo 12 weeks of CBT, with random assignment to oxytocin (24 IU, administered before each session) or placebo. (2 and 3) Cocaine arms, inpatient and outpatient: after a 1-week baseline for assessment of drug use, participants will undergo 6 and 12 weeks respectively of CBT, with random assignment to oxytocin (24 IU, administered before each session) or placebo.
Outcome measures: Principle outcome measures for the outpatient arms will be TA measured at several points during CBT, treatment retention, and attendance at CBT sessions. Secondary outcome measures are drug use during treatment and at follow-up, drug craving during treatment and at follow-up, stress reduction during treatment and at follow-up, HIV risk behaviors during treatment and at follow-up, behavioral performance on various tasks, and neural response to these tasks for the imaging subgroup. The outcome measures for the inpatient arm will be the same as for the outpatient arms with the exception of drug use during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methadone | Placebo comparator | Behavioral: Cognitive Behavioral Therapy, Drug: Intranasal Oxytocin, Drug: PlaceboIntranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients |
| Outpatient Cocaine | Placebo comparator | Behavioral: Cognitive Behavioral Therapy, Drug: Intranasal Oxytocin, Drug: PlaceboIntranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients |
| Inpatient Cocaine | Placebo comparator | Behavioral: Cognitive Behavioral Therapy, Drug: Intranasal Oxytocin, Drug: PlaceboIntranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be between age 18 and 65.
- Methadone arm only: opiate dependence for the past year determined by clinical exam, opiate-positive urine during screening and diagnosis confirmed by SCID.
- Cocaine outpatient arm: cocaine dependence determined by clinical exam, cocaine-positive urine during screening and diagnosis confirmed by SCID.
- Cocaine inpatient arm: Cocaine dependence determined by clinical exam during screening and diagnosis confirmed by SCID.
- Control participants: cocaine dependent and non-drug using, will be recruited to provide appropriate matches for subjects in the two treatment arms with respect to the following characteristics: age, gender, IQ, socioeconomic factors, and years of education.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyIntranasal oxytocin given in the context of cognitive behavioral therapy | Behavioural | Inpatient Cocaine, Methadone, Outpatient Cocaine |
| Intranasal OxytocinIntranasal oxytocin given in the context of cognitive behavioral therapy | Drug | Inpatient Cocaine, Methadone, Outpatient Cocaine |
| PlaceboPlacebo given in the context of cognitive behavioral therapy | Drug | Inpatient Cocaine, Methadone, Outpatient Cocaine |
Primary outcome
Therapeutic Alliance
Time frame: Post 12 weeks treatment with cognitive behavioral therapy
Penn Helping Alliance Questionnaire containing 19 questions with possible scores from 19(low therapeutic alliance)-114(high therapeutic alliance). Working Alliance Inventory containing 36 questions with possible scores from 36(low therapeutic alliance)-252 (high therapeutic alliance).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11709163Aharon I, Etcoff N, Ariely D, Chabris CF, O'Connor E, Breiter HC. Beautiful faces have variable reward value: fMRI and behavioral evidence. Neuron. 2001 Nov 8;32(3):537-51. doi: 10.1016/s0896-6273(01)00491-3.
- Background: PubMed 15089969Amico JA, Mantella RC, Vollmer RR, Li X. Anxiety and stress responses in female oxytocin deficient mice. J Neuroendocrinol. 2004 Apr;16(4):319-24. doi: 10.1111/j.0953-8194.2004.01161.x.
- Background: PubMed 7950665Anderson-Hunt M, Dennerstein L. Increased female sexual response after oxytocin. BMJ. 1994 Oct 8;309(6959):929. doi: 10.1136/bmj.309.6959.929. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary R Lee, M.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive Behavioral Therapy and Intranasal Oxytocin in people with Drug Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Alliance (time frame: Post 12 weeks treatment with cognitive behavioral therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00975416, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.