Insomnia and Drug Relapse Risk

• Sponsor: Butler Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00253890
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 137
• Location: 1
• Arms: 2
• Duration (Months): 55
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purposes of this study are:

1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and

2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.

Condition or Disease	Intervention/Treatment	Phase
Poor Quality Sleep; Opiate Addiction	Drug: Trazodone; Drug: Placebo	Phase 3

Detailed Description

Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Insomnia and Drug Relapse Risk
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Trazodone 50-150mg (50mg capsules) at bedtime for 90 days	Drug: Trazodone; 50 mg 1-3 capsules at bedtime for 3 months; Other Names: Desyrel Oleptro Beneficat Deprax Desirel Molipaxin Thombran Trazorel Trialodine Trittico Mesyrel
Placebo Comparator: Placebo 1-3 capsules at bedtime for 90 days	Drug: Placebo; 1-3 at bedtime; Other Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. Sleep Quality, as Measured by Total Sleep Time [Baseline to 1-month]

   Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Recent methadone maintenance enrollment

• Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)

• No medical contraindications to trazodone

Exclusion Criteria:

• Methadone maintenance enrollment not recent

• No sleep complaints as measured by the PSQI

• Medical contraindications to trazodone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Butler Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• Butler Hospital
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Michael D Stein, MD, Rhode Island Hospital
• Study Director: Rogers Griffith, MD, The Miriam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Stein, MD, Director, General Medicine Research, Butler Hospital
• ClinicalTrials.gov Identifier: NCT00253890
• Other Study ID Numbers: R01DA020479; R01DA020479-01
• First Posted: Nov 15, 2005
• Last Update Posted: Dec 11, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Michael Stein, MD, Director, General Medicine Research, Butler Hospital: sleep quality; methadone; substance use
• Additional relevant MeSH terms: Opioid-Related Disorders; Trazodone

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 8 methadone maintenance clinics in the Providence, RI area.

Arm/Group Title	Trazodone	Placebo
Arm/Group Description	50-150mg at bedtime	1-3 capsules at bedtime
Period Title: Overall Study
STARTED	69	68
COMPLETED	62	61
NOT COMPLETED	7	7

Baseline Characteristics

Arm/Group Title	Trazodone	Placebo	Total
Arm/Group Description	50-150mg at bedtime	1-3 at bedtime	Total of all reporting groups
Overall Participants	69	68	137
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	69 100%	68 100%	137 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.0 (8.8)	38.5 (8.7)	38.2 (8.6)
Sex: Female, Male (Count of Participants)
Female	34 49.3%	39 57.4%	73 53.3%
Male	35 50.7%	29 42.6%	64 46.7%
Region of Enrollment (participants) [Number]
United States	69 100%	68 100%	137 100%

Outcome Measures

1. Primary Outcome

Title	Sleep Quality, as Measured by Total Sleep Time
Description	Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.
Time Frame	Baseline to 1-month

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	Trazodone	Placebo
Arm/Group Description	50-150mg at bedtime	1-3 capsules at bedtime
Measure Participants	67	67
Mean (Standard Deviation) [minutes]	339 (136)	329 (124)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trazodone, Placebo
	Comments	Change in sleep quality was assessed by calculating gain scores. We used a 2-sided t-test to report mean change.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	35.7
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Trazodone		Placebo
Arm/Group Description	50-150mg at bedtime		1-3 at bedtime
All Cause Mortality
	Trazodone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Trazodone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/69 (0%)		0/68 (0%)
Other (Not Including Serious) Adverse Events
	Trazodone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/69 (0%)		0/68 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.