Trial · NCT01100853

Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

NCT01100853, Phase 3, Completed, University of Pennsylvania; results first posted 2014-01-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland. Trials, record NCT01100853. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01100853

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland
NCT number: NCT01100853
Status: Completed
Phases: Phase 3
Enrollment: 100 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Amphetamine Dependence
Interventions: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks
First posted: 2010-04-09
Last updated: 2018-03-06
Other registries' IDs: eudract:2009-013647-10
Results first posted: 2014-01-13

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number Negative Urines (Proportion Negative Urines)	24 Weeks
Primary	Number Negative Urines (Proportion Negative Urines) Amphetamine	24 weeks
Secondary	Amphetamine Craving Scale	24 weeks	The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100.
Secondary	Beck Depression Inventory	24 weeks	The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms.
Secondary	Risk Assessment Battery	24 weeks	The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1.
Secondary	Prior Admissions to Vogur Hospital	Baseline	Number of prior admissions due to substance dependence. The term "prior admissions" refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number Negative Urines (Proportion Negative Urines)	24 Weeks	Urine drug screens negative amphetamine	Urine Drug Screen	NUMBER
SECONDARY	Amphetamine Craving Scale	24 weeks		VAS Score	MEAN
SECONDARY	Beck Depression Inventory	24 weeks		BDI Score	MEAN
SECONDARY	Risk Assessment Battery	24 weeks		Total Score	MEAN
SECONDARY	Prior Admissions to Vogur Hospital	Baseline		Number of admissions	MEAN
PRIMARY	Number Negative Urines (Proportion Negative Urines) Amphetamine	24 weeks		Urine Drug Screen	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number Negative Urines (Proportion Negative Urines)	VIVITROL Injection, 24 Weeks	560		Urine Drug Screen
Number Negative Urines (Proportion Negative Urines)	VIVITROL Placebo Injection, 24 Weeks	634		Urine Drug Screen
Amphetamine Craving Scale	VIVITROL Injection, 24 Weeks	40.9	Standard Deviation 4	VAS Score
Amphetamine Craving Scale	VIVITROL Placebo Injection, 24 Weeks	46.92	Standard Deviation 4.38	VAS Score
Beck Depression Inventory	VIVITROL Injection, 24 Weeks	14.63	Standard Deviation 1.40	BDI Score
Beck Depression Inventory	VIVITROL Placebo Injection, 24 Weeks	14.08	Standard Deviation 1.09	BDI Score
Risk Assessment Battery	VIVITROL Injection, 24 Weeks	7.14	Standard Deviation .62	Total Score
Risk Assessment Battery	VIVITROL Placebo Injection, 24 Weeks	5.98	Standard Deviation .43	Total Score
Prior Admissions to Vogur Hospital	VIVITROL Injection, 24 Weeks	5.78	Standard Deviation .87	Number of admissions
Prior Admissions to Vogur Hospital	VIVITROL Placebo Injection, 24 Weeks	4.88	Standard Deviation .63	Number of admissions

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	VIVITROL Injection, 24 Weeks	51
Overall Study	STARTED	VIVITROL Placebo Injection, 24 Weeks	49
Overall Study	COMPLETED	VIVITROL Injection, 24 Weeks	24
Overall Study	COMPLETED	VIVITROL Placebo Injection, 24 Weeks	26
Overall Study	NOT COMPLETED	VIVITROL Injection, 24 Weeks	27
Overall Study	NOT COMPLETED	VIVITROL Placebo Injection, 24 Weeks	23

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea, diarrhea, discomfort/pain from stomach, heartburn	Gastrointestinal disorders	VIVITROL Injection, 24 Weeks	8	51	12
other	Nausea, diarrhea, discomfort/pain from stomach, heartburn	Gastrointestinal disorders	VIVITROL Placebo Injection, 24 Weeks	7	49	13
other	Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	VIVITROL Injection, 24 Weeks	0	51	0
other	Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	VIVITROL Placebo Injection, 24 Weeks	5	49	8
other	Symptoms of depression and/or anxiety	Psychiatric disorders	VIVITROL Injection, 24 Weeks	5	51	5
other	Symptoms of depression and/or anxiety	Psychiatric disorders	VIVITROL Placebo Injection, 24 Weeks	2	49	2
other	Dizziness, fatigue, fainting sensation	Nervous system disorders	VIVITROL Injection, 24 Weeks	6	51	7
other	Dizziness, fatigue, fainting sensation	Nervous system disorders	VIVITROL Placebo Injection, 24 Weeks	3	49	3
other	Elevated ALT level >5 times normal range	Hepatobiliary disorders	VIVITROL Injection, 24 Weeks	1	51	1
other	Elevated ALT level >5 times normal range	Hepatobiliary disorders	VIVITROL Placebo Injection, 24 Weeks	2	49	2

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	VIVITROL Injection, 24 Weeks
Total, all-cause mortality	VIVITROL Placebo Injection, 24 Weeks
Total, other adverse events	VIVITROL Injection, 24 Weeks	28	51
Total, other adverse events	VIVITROL Placebo Injection, 24 Weeks	27	49
Total, serious adverse events	VIVITROL Injection, 24 Weeks	9	51
Total, serious adverse events	VIVITROL Placebo Injection, 24 Weeks	7	49

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P50DA012756	Innovative Approaches for Cocaine Pharmacotherapy	KAMPMAN, KYLE MATTHEW	UNIVERSITY OF PENNSYLVANIA	NATIONAL INSTITUTE ON DRUG ABUSE	1999 to 2013

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
VIVITROL Injection, 24 Weeks vs VIVITROL Placebo Injection, 24 Weeks: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01100853

GET https://conductscience.org/api/trials/v1/NCT01100853/events?page=2

API reference For AI assistants