Project iN: Intermittent Naltrexone Among Polysubstance Users

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT01723384
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is inexpensive and has few toxicities but the standard daily regimen for naltrexone is problematic as patients forget to take the medication. Given the challenges in daily dosing, alternate regimen schedules have been proposed to increase efficacy and expand the population that may benefit from this pharmacologic agent. One approach is intermittent targeted administration of naltrexone, whereby individuals take the medication as-needed in anticipation of substance use or during periods of craving. Administration of naltrexone prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone has shown efficacy in reducing heavy alcohol use. However, there have been no studies assessing intermittent targeted dosing of naltrexone among methamphetamine-using and binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those who abuse more than one substance are urgently needed. The aims of this study are to determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among non-dependent methamphetamine-using and binge-drinking MSM.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine; Alcohol	Drug: Intermittent Oral Naltrexone; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Naltrexone Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks.	Drug: Intermittent Oral Naltrexone
Placebo Comparator: Placebo Intermittent oral placebo to be taken on an as-needed basis for 8 weeks	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Feasibility of Retaining Participants in Trial [proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant]

   Proportion of persons retained by study arm.

2. Acceptability to Taking Medication [2 month follow-up]

   Mean number of pills taken weekly, as determined by recorded openings from an electronic monitoring device for study medication pill dispensers

3. Tolerability to Study Drug, as Measured by Adverse Events [2 months]

   Frequency of Adverse Events, by arm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. male gender or transgender male-to-female

2. self-reported anal sex with men in the prior six months while under the influence of meth and/or alcohol

3. self-reported meth use at least bi-weekly in the prior three months

4. at least weekly binge drinking (five or more drinks on a single drinking session) in the prior three months

1. interested in reducing meth use and/or binge drinking 5) HIV-negative by rapid test or medical record of HIV infection 6) no current acute illnesses requiring prolonged medical care 7) no chronic illnesses that are likely to progress clinically during trial participation 8) able and willing to provide informed consent and adhere to visit schedule
2. age 18-70 years 10) baseline complete blood count (CBC), total protein, albumin, glucose, alkaline phosphatase, creatinine, blood urea nitrogen (BUN), and electrolytes without clinically significant abnormalities as determined by study clinician in conjunction with symptoms, physical exam, and medical history

Exclusion Criteria:

1. any psychiatric (e.g., depression with suicidal ideation) or medical condition that would preclude safe participation in the protocol

2. known allergy or previous adverse reaction to naltrexone

3. current use of or dependence on any opioids or a known medical condition which currently requires or may likely require opioid analgesics

4. opioid-positive urine test at enrollment

5. current cluster of differentiation 4 (CD4) count < 200 cells/mm3

6. moderate or severe liver disease (aspartate aminotransferase, alanine aminotransferase, or total bilirubin > 3 times upper limit of normal)

7. impaired renal function (creatinine clearance < 60 ml/min)

8. currently participating in another research study

9. meth or alcohol dependence as determined by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) criteria

10. any condition that, in the principal investigator and/or study clinician's judgment interferes with safe participation or adherence to study procedures.

11. unwillingness to provide minimum locator for information

12. not having a cellular phone that can send or receive a text message

13. plans to leave the Bay Area during study follow-up

14. not comfortable speaking and reading English, enough to participate in a program in English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco Department of Public Health, Substance Use Research Unit	San Francisco	California	United States	94102

Sponsors and Collaborators

• University of California, San Francisco
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Glenn-Milo Santos, PhD, University of California, San Francisco
• Study Director: Jason Euren, MA, San Francisco Department of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glenn-Milo Santos, Assistant Professor, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01723384
• Other Study ID Numbers: 12-09809; R36DA035109-01
• First Posted: Nov 7, 2012
• Last Update Posted: Apr 23, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Glenn-Milo Santos, Assistant Professor, University of California, San Francisco: methamphetamine; alcohol; HIV; sexual behavior
• Additional relevant MeSH terms: Naltrexone

Study Results

Participant Flow

Arm/Group Title	Naltrexone	Placebo
Arm/Group Description	Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks. Intermittent Oral Naltrexone	Intermittent oral placebo to be taken on an as-needed basis for 8 weeks Placebo
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Naltrexone	Placebo	Total
Arm/Group Description	Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks. Intermittent Oral Naltrexone	Intermittent oral placebo to be taken on an as-needed basis for 8 weeks Placebo	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	15 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.7 (10)	42.3 (10)	43 (9.3)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	15 100%	15 100%	30 100%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Retaining Participants in Trial
Description	Proportion of persons retained by study arm.
Time Frame	proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone	Placebo
Arm/Group Description	Naltrexone	Placebo
Measure Participants	15	15
Number [percentage that completed study]	100	86.7

2. Primary Outcome

Title	Acceptability to Taking Medication
Description	Mean number of pills taken weekly, as determined by recorded openings from an electronic monitoring device for study medication pill dispensers
Time Frame	2 month follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone	Placebo
Arm/Group Description	Naltrexone	Placebo
Measure Participants	15	15
Mean (Standard Deviation) [number of wisepill openings by week]	2.2 (1)	1.9 (1)

3. Primary Outcome

Title	Tolerability to Study Drug, as Measured by Adverse Events
Description	Frequency of Adverse Events, by arm
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone	Placebo
Arm/Group Description	Naltrexone	Placebo
Measure Participants	15	15
Nausea	4	2
Headaches	2	1
Upper respiratory tract infection	2	4

Adverse Events

Arm/Group Title	Naltrexone		Placebo
Arm/Group Description	Naltrexone		Placebo
All Cause Mortality
	Naltrexone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Naltrexone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Naltrexone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/15 (53.3%)		6/15 (40%)
General disorders
Nausea	4/15 (26.7%)	4	2/15 (13.3%)	2
Headaches	2/15 (13.3%)	2	1/15 (6.7%)	1
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection	2/15 (13.3%)	2	4/15 (26.7%)	4

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.