INTERVENTIONALCOMPLETEDNCT01024335

Dronabinol Naltrexone Treatment for Opioid Dependence

The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone tolerability, resulting in better naltrexone compliance and treatment retention, and ultimately a reduction in opioid use and relapse rates.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2018-06-18

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2, PHASE3
Enrollment: 60 (ACTUAL)
Start date: 2010-01
Sponsor: New York State Psychiatric Institute
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Present in registry snapshot

The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We are proposing a randomized, double-blind, placebo controlled, parallel-groups, 8 week study of relapse prevention in opioid-dependent individuals. Participants will be randomized into one of two conditions (1) Naltrexone and Placebo (N=20) and (2) Naltrexone and dronabinol 15 mg bid (N=40). Treatment will be delivered in an outpatient setting except for the initial phase of inpatient detoxification, lasting 8 days. A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections), while dronabinol or placebo will be taken daily. In addition, patients will receive a psychosocial intervention that will include elements of motivational interviewing and cognitive-behavioral relapse prevention therapy. The primary aim is to test the efficacy of dronabinol in improving tolerability of naltrexone induction and reducing attrition during detoxification and the first two months of naltrexone treatment. The primary outcome will be the severity of opiate withdrawal and craving. The secondary outcome will be will be retention in treatment at study's end.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Interventions

What was registered

DRUG

injectable naltrexone and dronabinol

Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.

DRUG

Naltrexone and placebo

Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.

Source-reported results

Results posted to the registry

2 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 2
Secondary outcomes: 0
Statistical analyses: 0
Adverse-event terms: 12

PRIMARYOpiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .

Time frame: 3x/week during 8 weeks of the trial or study participation
Measure: MEAN · units on a scale
Reporting status: POSTED

The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.

Group	N	Value	Spread / interval
Naltrexone and Placebo	20	11.16	6.13
Naltrexone and Dronabinol	40	13.36	10.55

PRIMARYRetention

Time frame: retention over 8 weeks.
Measure: NUMBER · participants
Reporting status: POSTED

Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.

Group	N	Value	Spread / interval
Naltrexone and Placebo	20	7	-
Naltrexone and Dronabinol	40	14	-

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Not accepted

Inclusion criteria

1\. Adult, aged 18-60.
2\. Meets Diagnostic and Statistical Manual -IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
3\. Have a history of marijuana use (more than 30 occasions lifetime)
4\. Voluntarily seeking treatment for opioid dependence
5\. In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges.
6\. Able to give informed consent.

Exclusion criteria

1\. Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal.
2\. Patients meeting current criteria for cannabis abuse or dependence, and those who used cannabis in the week prior to study entry as documented by the positive toxicology
3\. Current Diagnostic and Statistical Manual -IV criteria of other substance use disorders. Exceptions include cannabis abuse or dependence, nicotine dependence, cocaine abuse or dependence, alcohol abuse or alcohol dependence without physiological dependence as long as opioid dependence is a primary disorder. Alcohol dependence with physiological dependence is exclusionary.
4\. Significant current suicidal risk or 1 or more suicide attempts within the past year
5\. History of accidental drug overdose in the last three years defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
6\. Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
7\. Active psychiatric disorder which might interfere with participation or make participation hazardous, including Diagnostic and Statistical Manual -IV organic mental disorder, psychotic disorder, or bipolar disorder with mania
8\. History of allergic reaction, adverse reaction, or sensitivity to any study medication.
9\. Acute hepatitis with serum glutamic-oxaloacetic transaminase or serum glutamic-pyruvic transaminase \> 3 times the upper end of the laboratory normal range (chronic hepatitis is acceptable as we have found naltrexone treatment well tolerate and safe among patients with chronic hepatitis)

primary outcomes

primary measures

Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .

Time frame: 3x/week during 8 weeks of the trial or study participation

Retention

Time frame: retention over 8 weeks.

Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 52b45cb2-1b9a-496b-a77a-ce1fd1c9ff9c
Retrieved: 11/09/2026, 14:15:29
SHA-256: 9c30a8ec8112226c2542c409b5ab4d818240f0bed5509aed7d7ce00aa800e2d3

Event	System	Groups: affected / at risk
Pruritis and facial swelling	General disorders	Naltrexone and Placebo: 0 / 20 · Naltrexone and Dronabinol: 1 / 40
Dehydration	General disorders	Naltrexone and Placebo: 1 / 20 · Naltrexone and Dronabinol: 0 / 40
Kidney infection and dislocated arm	General disorders	Naltrexone and Placebo: 1 / 20 · Naltrexone and Dronabinol: 0 / 40

Event	System	Groups: affected / at risk
Insomnia	Psychiatric disorders	Naltrexone and Placebo: 7 / 20 · Naltrexone and Dronabinol: 17 / 40
Mood changes	Psychiatric disorders	Naltrexone and Placebo: 4 / 20 · Naltrexone and Dronabinol: 5 / 40
Increased/decreased appetite	General disorders	Naltrexone and Placebo: 2 / 20 · Naltrexone and Dronabinol: 2 / 40
Nausea/vomiting	Gastrointestinal disorders	Naltrexone and Placebo: 2 / 20 · Naltrexone and Dronabinol: 5 / 40
Diarrhea	Gastrointestinal disorders	Naltrexone and Placebo: 2 / 20 · Naltrexone and Dronabinol: 7 / 40
Headache	General disorders	Naltrexone and Placebo: 2 / 20 · Naltrexone and Dronabinol: 3 / 40
Body Aches	General disorders	Naltrexone and Placebo: 1 / 20 · Naltrexone and Dronabinol: 3 / 40
GI Distress	Gastrointestinal disorders	Naltrexone and Placebo: 3 / 20 · Naltrexone and Dronabinol: 4 / 40
Sweating/chills	General disorders	Naltrexone and Placebo: 0 / 20 · Naltrexone and Dronabinol: 4 / 40

Dronabinol Naltrexone Treatment for Opioid Dependence

Registry results are available

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

injectable naltrexone and dronabinol

Naltrexone and placebo

Results posted to the registry

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .

Retention

Locally readable linked articles

Overall Study

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Naltrexone and Placebo

Naltrexone and Dronabinol