Trial Outcomes & Findings for Oxytocin and Cognitive Behavioral Therapy in Drug Dependence (NCT NCT00975416)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

63 participants

Primary outcome timeframe

Post 12 weeks treatment with cognitive behavioral therapy

Results posted on

2015-11-20

Participant Flow

Study was conducted at an inpatient treatment center. Screening was included in the study. Also, baseline characterization was done as a within subject study with tasks and measures before randomization to oxytocin or placebo and treatment with cognitive behavioral therapy. Methadone and outpatient cocaine arms did not recruit participants.

63 participants were screened, 30 were randomized. Subjects completed a battery of tasks and measures on oxytocin and on placebo before entering into randomized treatment phase where they were assisgned to the oxytocin or placebo arm with all subjects receiving cognitive behavioral therapy during the treatment phase.

Participant milestones

Participant milestones
Measure	Inpatient Cocaine Oxytocin Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy	Inpatient Cocaine Placebo Placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Placebo given in the context of cognitive behavioral therapy
Overall Study STARTED	14	16
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Inpatient Cocaine Oxytocin Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy	Inpatient Cocaine Placebo Placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Placebo given in the context of cognitive behavioral therapy
Overall Study early discharge from tx	3	5

Baseline Characteristics

Oxytocin and Cognitive Behavioral Therapy in Drug Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inpatient Cocaine Oxytocin n=14 Participants Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy	Inpatient Cocaine Placebo n=16 Participants Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Intranasal Placebo given in the context of cognitive behavioral therapy	Total n=30 Participants Total of all reporting groups
Age, Continuous	41.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	40.8 years STANDARD_DEVIATION 10.0 • n=7 Participants	40.9 years STANDARD_DEVIATION 9.9 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Post 12 weeks treatment with cognitive behavioral therapy

Population: Number of participants for analysis was determined by the number of participants who had post-treatment outcome measures.

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).

Outcome measures

Outcome measures
Measure	Inpatient Cocaine Oxytocin n=14 Participants Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy	Inpatient Cocaine Placebo n=16 Participants Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Intranasal placebo given in the context of cognitive behavioral therapy
Therapeutic Alliance Working Alliance Inventory	220.43 units on a scale Standard Deviation 20.55	223.13 units on a scale Standard Deviation 41.81
Therapeutic Alliance Penn Helping Alliance Questionnaire	99.23 units on a scale Standard Deviation 8.45	99.81 units on a scale Standard Deviation 10.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-treatment

Cocaine Craving Questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Methadone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Outpatient Cocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inpatient Cocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary R. Lee, M.D.

National Institute on Drug Abuse

Phone: 301-825-0545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place