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Withdrawal from Tobacco Use ^#721001

Protocol Release Date

February 20, 2015

Protocol Name From Source

This section will be completed when reviewed by an Expert Review Panel.

Description of Protocol

The Minnesota Withdrawal Scale - Revised offers a self-report protocol which reviews symptoms of withdrawal. This protocol has been validated for use with adults and adolescents.

Specific Instructions

Instructions for Use of the Minnesota Withdrawal Scale - Revised

1. There are two scales: a self-report and an observer scale. Several items do not appear in the observer scale because observers cannot reliably rate them.

2. On the self-report scale, the first nine items are the well-validated items and are the ones to be used if calculating a total withdrawal discomfort score. The other six are promising candidate items.

3. See the attached table to further compare the content of the scales with the criteria for DSM-V and ICD-10 nicotine/tobacco withdrawal and the contents of other withdrawal scales.

4. We have participants complete the scale both before and after quitting.

5. We have participants rate over the last 24 hours and observers rate over the last week. We usually require observers to see the participant on average 2 hours/day.

6. We use the 0-4 response option so that we can have verbal anchors for each response. Larger response options (e.g., 0-100) are likely more sensitive but may be more difficult to interpret.

7. The scale is not labeled a withdrawal scale because subjects (1) are confused by filling out a "withdrawal" scale prior to cessation, and (2) will sometimes not report a symptom during abstinence if they do not believe it is the result of withdrawal.

8. We encourage readers to read recent reviews of methodological issues in measuring tobacco withdrawal (see references 3 & 4).

Protocol

Behavior Rating Scale - Self-Report

Please rate yourself for the period for the last _______________

1. Angry, irritable, frustrated

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

2. Anxious, nervous

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

3. Depressed mood, sad

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

4. Desire or craving to smoke

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

5. Difficulty concentrating

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

6. Increased appetite, hungry, weight gain

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

7. Insomnia, sleep problems, awakening at night

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

8. Restless

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

9. Impatient

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

10. Constipation

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

11. Dizziness

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

12. Coughing

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

13. Dreaming or nightmares

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

14. Nausea

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

15. Sore throat

[ ] 0 none

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

Behavior Rating Scale - Observer-Rating

Rate the subject on the following symptoms according to whether you observed the symptom in the subject in the last ________________. It does not matter whether the subject complained of the symptom. We want to know whether you noticed the symptom.

a. Angry/irritable/frustrated

[ ] 0 not at all

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

b. Anxious/tense

[ ] 0 not at all

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

c. Depressed

[ ] 0 not at all

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

d. Restless/Impatient

[ ] 0 not at all

[ ] 1 slight

[ ] 2 mild

[ ] 3 moderate

[ ] 4 severe

1. How confident are you that this rating is accurate?

[ ] 0 not at all

[ ] 1 somewhat confident

[ ] 2 moderately confident

[ ] 3 very confident

Variables

Export Variables

Variable Name Variable ID Variable Description Version Mapping

PX721001_Tobacco_Use_Withdrawal_Angry PX721001010000 Please rate yourself for the period for the last - Angry, irritable, frustrated 4 N/A

PX721001_Tobacco_Use_Withdrawal_Anxious PX721001020000 Please rate yourself for the period for the last - Anxious, nervous 4 N/A

PX721001_Tobacco_Use_Withdrawal_Depressed PX721001030000 Please rate yourself for the period for the last - Depressed mood, sad 4 N/A

PX721001_Tobacco_Use_Withdrawal_Craving_Smoke PX721001040000 Please rate yourself for the period for the last - Desire or craving to smoke 4 N/A

PX721001_Tobacco_Use_Withdrawal_Difficulty_Concentrating PX721001050000 Please rate yourself for the period for the last - Difficulty concentrating 4 N/A

PX721001_Tobacco_Use_Withdrawal_Appetite PX721001060000 Please rate yourself for the period for the last - Increased appetite, hungry, weight gain 4 N/A

PX721001_Tobacco_Use_Withdrawal_Insomnia PX721001070000 Please rate yourself for the period for the last - Insomnia, sleep problems, awakening at night 4 N/A

PX721001_Tobacco_Use_Withdrawal_Restless PX721001080000 Please rate yourself for the period for the last - Restless 4 N/A

PX721001_Tobacco_Use_Withdrawal_Impatient PX721001090000 Please rate yourself for the period for the last - Impatient 4 N/A

PX721001_Tobacco_Use_Withdrawal_Constipation PX721001100000 Please rate yourself for the period for the last - Constipation 4 N/A

PX721001_Tobacco_Use_Withdrawal_Dizziness PX721001110000 Please rate yourself for the period for the last - Dizziness 4 N/A

PX721001_Tobacco_Use_Withdrawal_Coughing PX721001120000 Please rate yourself for the period for the last - Coughing 4 N/A

PX721001_Tobacco_Use_Withdrawal_Dreaming_Nightmares PX721001130000 Please rate yourself for the period for the last - Dreaming or nightmares 4 N/A

PX721001_Tobacco_Use_Withdrawal_Nausea PX721001140000 Please rate yourself for the period for the last - Nausea 4 N/A

PX721001_Tobacco_Use_Withdrawal_Sore_Throat PX721001150000 Please rate yourself for the period for the last - Sore throat 4 N/A

PX721001_Tobacco_Use_Withdrawal_Observed_Angry PX721001160000 Rate the subject on the following symptoms according to whether you observed the symptom in the subject in the last - Angry/irritable/frustrated 4 N/A

PX721001_Tobacco_Use_Withdrawal_Observed_Anxious PX721001170000 Rate the subject on the following symptoms according to whether you observed the symptom in the subject in the last -Anxious/tense 4 N/A

PX721001_Tobacco_Use_Withdrawal_Observed_Depressed PX721001180000 Rate the subject on the following symptoms according to whether you observed the symptom in the subject in the last -Depressed 4 N/A

PX721001_Tobacco_Use_Withdrawal_Observed_Restless PX721001190000 Rate the subject on the following symptoms according to whether you observed the symptom in the subject in the last -Restless/Impatient 4 N/A

PX721001_Tobacco_Use_Withdrawal_Confident_Rating_Accurate PX721001200000 How confident are you that this rating is accurate? 4 N/A

Selection Rationale

The Minnesota Withdrawal Scale is a widely used validated instrument which measures withdrawal symptoms.

Source

www.uvm.edu/~hbpl/?Page=minnesota/default.html

Hughes, J. R., & Hatsukami, D. K. (1986). Signs and symptoms of tobacco withdrawal. Archives of General Psychiatry, 43, 289-294.

Minnesota Nicotine Withdrawal Scale - Revised. The University of Vermont, 21 Aug. 2012. Web. 23 Sept. 2014.

Life Stage

Adult

Language

Arabic, Chinese, Czech, Dutch, English, French, German, Italian, Japanese, Korean, Portuguese, Russian, Spanish, Swedish

Participant

Adults 18 and over

Personnel and Training Required

None

Equipment Needs

None

Standards

Standard Name ID Source

Common Data Elements (CDE) Tobacco Use Minnesota Withdrawal Scale Assessment Scale 4719216 CDE Browser

General References

The website for the scales is http://www.uvm.edu/~hbpl. The scales were originally reported in 1986 (Reference 2). Five articles have described the psychometrics of the scale (References 3-7). Three articles have comprehensively reviewed what is known about tobacco withdrawal (References 1, 4, 8).

Hughes, J. R. (2007). The effects of abstinence from tobacco: Valid symptoms and time course. Nicotine & Tobacco Research, 9, 315-327.

Hughes, J. R., & Hatsukami, D. K. (1986). Signs and symptoms of tobacco withdrawal. Archives of General Psychiatry, 43, 289-294.

Shiffman, S., West, R. J., & Gilbert, D. G. (2004). Recommendation for the assessment of tobacco craving and withdrawal in smoking cessation trials. Nicotine & Tobacco Research, 6, 599-614.

Hughes, J. R. (2007). Measurement of the effects of abstinence from tobacco. A qualitative review. Psychology of Addictive Behaviors, 21, 127-137.

West, R., Ussher, M., Evans, M., Rashid, M. (2006). Assessing DSM-IV nicotine withdrawal symptoms: A comparison and evaluation of five different scales. Psychopharmacology, 184, 619-627.

Etter, J. F., & Hughes, J. R. (2006). A comparison of the psychometric properties of three cigarette withdrawal scales. Addiction, 101, 362-372.

Javitz, H., Lerman, C., & Swan, G. (2012). Comparative dynamics of four smoking withdrawal symptom scales. Addiction, epub ahead of print.

Hughes, J. R. (2007). The effects of abstinence from tobacco: Etiology, determinants, epidemiology, significance. Nicotine & Tobacco Research, 9, 329-339.

World Health Organization. (1993). The ICD-10 classification of mental and behavioural disorders. Diagnostic criteria for research. Geneva, Switzerland: World Health Organization.

Etter, J. (2005). Self-administered questionnaire to measure cigarette withdrawal symptoms: The Cigarette Withdrawal Scale. Nicotine & Tobacco Research, 7, 47-57.

West, R., & Hajek, P. (2004). Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal. Psychopharmacology, 177, 195-199.

McNair, D. M., Lorr, J., & Droppelman, L. F. (1992). Profile of mood states manual. North Tonawanda, NY: Multi-Health Systems.

Shiffman, S., & Jarvik, M. E. (1976). Smoking withdrawal symptoms in two weeks of abstinence. Psychopharmacologia, 50, 35-39.

Schneider, N. G., & Jarvik, M. E. (1984). Time course of smoking withdrawal symptoms as a function of nicotine replacement. Psychopharmacology, 82, 143-144.

Welsch, S. K., Smith, S. S., Wetter, D. W., Jorenby, D. E., Fiore, M. C., & Baker, T. B. (1999). Development and validation of the Wisconsin Smoking Withdrawal Scale. Experimental and Clinical Psychopharmacology, 7(4), 354-361.

Shiffman, S., Paty, J. A., Gnys, M., Kassel, J. A., & Hickcox, M. (1996). First lapses to smoking: Within-subjects analysis of real-time reports. Journal of Consulting and Clinical Psychology, 64, 366-379.

Hughes, J. R., Helzer, J. E., & Lindberg, S. A. (2006). Prevalence of DSM/ICD-defined nicotine dependence. Drug and Alcohol Dependence, 85, 91-102.

Mode of Administration

Self-administered questionnaire and clinical assessment

Derived Variables

None

Requirements

Requirement Category Required

Average time of greater than 15 minutes in an unaffected individual No

Major equipment No

Specialized requirements for biospecimen collection No

Specialized training No

Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Please cite use of the PhenX Toolkit as: http://www.phenxtoolkit.org - April 11, 2017, Ver 21.0

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